No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00816063020790 | 211377 | Scanner, wand upgrade | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D Plus wand upgrade | |
2 | 00816063020776 | 211573 | Scanner, mobile configuration | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D Plus upgrade mobile configuration | |
3 | 00816063020752 | 211492 | Scanner, mobile configuration | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D Plus US mobile configuration | |
4 | 00816063020707 | 211485 | Scanner, cart configuration | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D Plus US cart configuration | |
5 | 00816063020608 | 209174 | Scanner Sleeve | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | iTero Element Barrier Sleeves | |
6 | 00816063021360 | SW-0000159 | ClinCheck Pro 6 | NXC | Aligner, Sequential | 2 | ClinCheck | |
7 | 00816063020493 | 205929 | Scanner | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D | |
8 | 00816063021070 | 211789 | DOA Kits | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | DOA Kit, Element 2 Plus | |
9 | 00816063020011 | 1011 | Retainer | DYW | Bracket, Plastic, Orthodontic | 2 | Invisalign | |
10 | 00816063020004 | 8500 | 8500 | Sequential Aligners | NXC | Aligner, Sequential | 2 | Invisalign Full |
11 | 00816063020073 | 8528 | Aligner | NXC | Aligner, Sequential | 2 | Invisalign i7 | |
12 | 00816063020998 | 211889 | Wand RMAs | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | Packed Element Plus Scanning Unit, RMA | |
13 | 00816063020813 | 211899 | Scanner, mobile configuration | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D Plus Ready US Mobile configuration | |
14 | 00816063020738 | 211490 | Scanner, mobile configuration | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | iTero Element 2 Plus mobile configuration | |
15 | 00816063020721 | 211572 | Scanner, upgrade cart configuration | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D Plus upgrade cart configuration | |
16 | 00816063020714 | 211376 | Scanner, upgrade cart configuration | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | iTero Element 2 Plus upgrade cart configuration | |
17 | 00816063020646 | 209157 | Scanner Upgrade Kit | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D LC Upgrade, Kit US | |
18 | 00816063020615 | 204284 | Scanner Sleeves | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D Sleeves | |
19 | 00816063020592 | 9027 | Aligner | NXC | Aligner, Sequential | 2 | Invisalign Swift | |
20 | 00816063020585 | 109236 | Scanner Sleeve | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | iTero Element Scanner Sleeve (25pcs/Box) | |
21 | 00816063020578 | 206856 | Scanner Upgrade Kit | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D Upgrade kit Laptop Configuration | |
22 | 00816063021094 | 212270 | DOA Kits | NTK | Caries Detector, Laser Light, Transmission | 2 | DOA Kit, 5D US Plus | |
23 | 00816063021018 | 212261 | Wand RMAs | NTK | Caries Detector, Laser Light, Transmission | 2 | Packed 5D Plus US Scanning Unit, RMA | |
24 | 00816063020257 | 9006 | 9006 | Sequential Aligner | NXC | Aligner, Sequential | 2 | Invislign First - Moderate |
25 | 00816063021001 | 212260 | Packed 5D Plus Scanning Unit, RMA | NTK | Caries Detector, Laser Light, Transmission | 2 | Packed 5D Plus Scanning Unit, RMA | |
26 | 00816063020837 | 211385 | Scanner computer unit | NOF,NTK | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations,Caries Detector, Laser Light, Transmission | 2 | iTero Computing Unit | |
27 | 00816063020523 | 9025 | Aligner | NXC | Aligner, Sequential | 2 | Invisalign Signature Smile | |
28 | 00816063020448 | 9021 | Sequential Aligner | NXC | Aligner, Sequential | 2 | Invisalign Signature Smile | |
29 | 00816063021025 | 212203 | Wand RMAs | NTK | Caries Detector, Laser Light, Transmission | 2 | Packed 5D Plus Lite Scanning Unit, RMA | |
30 | 00816063020981 | 211563 | WS service | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | iTero Element Plus wheel stand, service | |
31 | 00816063020844 | 211386 | Scanner computer unit | NOF,NTK | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations,Caries Detector, Laser Light, Transmission | 2 | iTero Mobile Computing Unit | |
32 | 00816063020172 | 8567 | Retainer | DYT | Maintainer, Space Preformed, Orthodontic | 1 | Vivera Realine | |
33 | 00816063020165 | 8800 | Aligner | NXC | Aligner, Sequential | 2 | Invisable Aligner System | |
34 | 00816063020066 | 8523 | Aligner | NXC | Aligner, Sequential | 2 | Invisalign Lite | |
35 | 00816063020035 | 8506 | 8506 | Aligner | NXC | Aligner, Sequential | 2 | Invisalign Teen |
36 | 00816063020769 | 211372 | Scanner, mobile configuration | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | iTero Element 2 Plus upgrade mobile configuration | |
37 | 00816063020677 | 107806 | Scanner | EJP | Articulators | 1 | iTero Articulator Kit | |
38 | 00816063020509 | 206160 | Scanner | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero Element 5D Laptop Configuration | |
39 | 00816063020462 | 9019 | Sequential Aligner | NXC | Aligner, Sequential | 2 | Invisalign Deluxe Smile | |
40 | 00816063020288 | 202965 | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | iTero Element 2 | ||
41 | 00816063020264 | 9007 | Sequential Aligner | NXC | Aligner, Sequential | 2 | Invisalign First-Comprehensive | |
42 | 00816063021032 | 209865 | PPC RMAs | NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 2 | Packed iTero Computing Unit RMA E2 Plus | |
43 | 00816063020875 | 211871 | Scanning unit | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero 5D Scanning Unit | |
44 | 00816063020868 | 211783 | Scanning unit | NTK | Caries Detector, Laser Light, Transmission | 2 | iTero 5D Scanning Unit | |
45 | 00816063020240 | 9016 | 9016 | Sequential Aligner | NXC | Aligner, Sequential | 2 | The Signature Smile |
46 | 00816063020233 | 9005 | 9005 | Sequential Aligner | NXC | Aligner, Sequential | 2 | NuMe |
47 | 00816063020226 | 9004 | 9004 | Sequential Aligners | NXC | Aligner, Sequential | 2 | NuMe |
48 | 00816063020202 | 9002 | 9002 | Sequential Aligners | NXC | Aligner, Sequential | 2 | Invisalign System - Lite |
49 | 00816063020196 | 9001 | 9001 | Sequential Aligners | NXC | Aligner, Sequential | 2 | Invisalign System - Moderate |
50 | 00816063020189 | 9000 | 9000 | Sequential Aligners | NXC | Aligner, Sequential | 2 | Invisalign System - Comprehensive |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00860006891206 | K173785 | Dandy Clear Aligners | ORTHLY, INC. | ||
2 | 00860006274368 | TSCA | Tru-Smile Clear Aligner | Tru-Smile | PHASE ORTHO, INC. | |
3 | 00860006274344 | PLCA | Phase Ortho Private Label Clear Aligner - Temporary Placeholder | Phase Ortho Private Label | PHASE ORTHO, INC. | |
4 | 00860006274320 | SSCA | Smile Shapers Clear Aligner - Zendura | Smile Shapers | PHASE ORTHO, INC. | |
5 | 00860006274306 | POCA | Phase Ortho Clear Aligner | Phase Ortho | PHASE ORTHO, INC. | |
6 | 00860005619016 | X | Clear Dental Aligner | Straight T Clear Dental Aligner | STRAIGHT-T LLC | |
7 | 00860003321751 | RA1 | OrthoFX Rescue aligner. Specialized purpose of bringing off track treatment back on track. | OrthoFX Rescue Aligner | ORTHOFX | |
8 | 00860003321706 | FXTetra | Updated UDI submission for Zendura material aligners. | OrthoFX | ORTHOFX | |
9 | 00860002380094 | FG0094 | The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that con The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctor-prescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient’s teeth gradually to the ideal position. | uLab Systems Dental Aligner | ULAB SYSTEMS, INC. | |
10 | 00860002380063 | FG0094 Rev. D | uLab Systems Dental Aligner | ULAB SYSTEMS, INC. | ||
11 | 00860002380056 | FG0094 | uLab Systems Dental Aligner | ULAB SYSTEMS, INC. | ||
12 | 00860002302355 | POCA | Discontinued product code. | Phase Ortho | DERBY DENTAL LABORATORY, INC | |
13 | 00860002302348 | TSCA | Clear sequential aligner / progressive orthodontic appliance system. | Tru-Smile | DERBY DENTAL LABORATORY, INC | |
14 | 00860002302317 | SSCA | Discontinued product code. | Smile Shapers | DERBY DENTAL LABORATORY, INC | |
15 | 00860002302300 | 01 | Discontinued - No longer in use. | Smile Shapers, Tru-Smile | DERBY DENTAL LABORATORY, INC | |
16 | 00860000937801 | 1 | Voodoo Clear Aligners are clear orthodontic aligners prescribed by a clinician t Voodoo Clear Aligners are clear orthodontic aligners prescribed by a clinician to treat malocclusion. The patient follows a set treatment plan designed by the provider or a third party and that produces a series of steps (or trays) that are then worn by the patient. The clinician provides periodic checkups to make sure treatment is progressing appropriately. | Voodoo Clear Aligners | VOODOO MANUFACTURING, INC. | |
17 | 00860000506007 | PRS-0063 | PRS-0063 | Sequential Aligners | Byte Aligner System | STRAIGHT SMILE LLC |
18 | 00856379007276 | 1000 | ASSY-500016 | SureSmile Aligner (10 hours/day) | SureSmile® Aligner | ORAMETRIX, INC. |
19 | 00856379007085 | 7.6 | SureSmile Aligner Software | ORAMETRIX, INC. | ||
20 | 00856379007047 | 3000 | SureSmile attachment template | ORAMETRIX, INC. | ||
21 | 00856379007030 | 2000 | SureSmile attachment template | ORAMETRIX, INC. | ||
22 | 00856379007023 | 1000 | SureSmile aligner | ORAMETRIX, INC. | ||
23 | 00856379007016 | 2000 | sureclear template | ORAMETRIX, INC. | ||
24 | 00856379007009 | 1000 | sureclear aligner | ORAMETRIX, INC. | ||
25 | 00850028222003 | CA0000000001 | The Concinnity Aligners™ are a custom clear aligner system. They are a series of The Concinnity Aligners™ are a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as an alternative to traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment.Intended Use / Indications for Use:The Concinnity Aligners™ is intended for orthodontic treatment and correction of misaligned and maloccluded permanent teeth (i.e. all second molars). | Concinnity Aligners | DRAKE PRECISION DENTAL LABORATORY, INC. | |
26 | 00850017524170 | NBYTETray | PRS-0063 | Sequential Aligners | Byte Night Aligners | STRAIGHT SMILE LLC |
27 | 00850017524163 | HBYTETray | PRS-0063 | Sequential Aligners | Byte Day Alignes | STRAIGHT SMILE LLC |
28 | 00850007728144 | 100-0365 | NIGHTTIME CLEAR ALIGNER REPLACEMENT ALIGNERS | ACCESS DENTAL LAB | ACCESS DENTAL LAB, LLC | |
29 | 00850007728137 | 100-0364 | NIGHTTIME CLEAR ALIGNER - REFINEMENT CORRECTIONS | ACCESS DENTAL LAB | ACCESS DENTAL LAB, LLC | |
30 | 00850007728120 | 100-0363 | NIGHTTIME CLEAR ALIGNERS-MIDCOURSE CORRECTIONS | ACCESS DENTAL LAB | ACCESS DENTAL LAB, LLC | |
31 | 00850007728113 | 100-0362 | NIGHTTIME CLEAR ALIGNERS-SEQUENTIAL ALIGNERS | ACCESS DENTAL LAB | ACCESS DENTAL LAB, LLC | |
32 | 00850007728045 | 100-0355 | REPLACEMENT ALIGNERS | REPLACEMENT ALIGNERS | ACCESS DENTAL LAB, LLC | |
33 | 00850007728021 | 100-0012 | REFINEMENT CORRECTION KIT | REFINEMENT CORRECTION KIT | ACCESS DENTAL LAB, LLC | |
34 | 00850007728014 | 100-0010 | MIDCOURSE CORRECTIONS KIT | MIDCOURSE CORRECTIONS KIT | ACCESS DENTAL LAB, LLC | |
35 | 00850007728007 | 100-0352 | sequential aligner system | sequential aligner | ACCESS DENTAL LAB, LLC | |
36 | 00850004223567 | FA-0001 | Candid Aligner System FA-0001 | Candid Aligner | CANDID CARE CO. | |
37 | 00850004223222 | FA-0003 | Candid Aligner System FA-0003 | Candid Aligner | CANDID CARE CO. | |
38 | D9393DS080 | 3DS08 | Orthodontic plastic aligner | 3D Predict | 3D SMILE USA, INC | |
39 | D918SCA0 | Aligners | Orthodontic appliance system, progressiveFDA PT: HJDC | SureCure | DIGITAL ORTHODONTIC CARE | |
40 | D865REF00051 | Aligner (Single-layer) | REF-05 | The ClearCorrect device is fabricated of clear thin thermoformed polyurethane pl The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
41 | D865REF00041 | Retainer | REF-04 | The ClearCorrect retainer device is fabricated of clear thin thermoformed polyur The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
42 | D865REF00031 | Aligner (Multi-layer) | REF-03 | The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-poly The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
43 | D865REF00021 | Engager Template | REF-02 | Engager template device accessory for use with the ClearCorrect System. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
44 | D865REF0002 | MFG-0101 1.0 | REF-02 | Engager template device accessory for use with the ClearCorrect System. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
45 | D865REF00011 | Aligner (Single-Layer) | REF-01 | The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane p The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
46 | D865REF0001 | MFG-0100 5.0 | REF-01 | The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane p The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. | ClearCorrect System | CLEARCORRECT OPERATING, LLC |
47 | D8410091U1M | 0091U | 0091U | Orthodontic Plastic Bracket (Sequential Aligners). Upper Tray | EZ-Align | DYNA FLEX OF MISSOURI, L.P. |
48 | D8410091L1D | 0091L | 0091L | Sequential Aligner (Lower Tray) | EZ-Align | DYNA FLEX OF MISSOURI, L.P. |
49 | D84100911Z | 0091 | 0091 | Clear Sequential Aligner System | EZ-Align | DYNA FLEX OF MISSOURI, L.P. |
50 | D819702400 | 70240 | Clear Image Aligner | SPECIALTY APPLIANCES, LLC |