| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00190707057183 | 426-056 | ADJUSTABLE FACEMASK-RED | DZB | Headgear, extraoral, orthodontic | 2 | FACEMASK | |
| 2 | 00190707053109 | 400-326 | .018 TISSUE GUARD- CLEAR 10 FT | ECI | BAND, ELASTIC, ORTHODONTIC | 1 | Ortho Organizers | |
| 3 | 00190707044329 | 702-360-10 | .022 UL4/5 -7T 0A 0O | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Elite Opti-MIM | |
| 4 | 00190707041151 | 4151-687 | Choice™ Weingart Pliers | JEX | PLIER, ORTHODONTIC | 1 | Masel | |
| 5 | 00190707041076 | 4151-653 | Choice™ Angled Bracket Removing Pliers | JEX | PLIER, ORTHODONTIC | 1 | Masel | |
| 6 | 00190707033491 | 4805-118 | .018 Upper CV Super Force Natural Form Archwires | DZC | WIRE, ORTHODONTIC | 1 | Masel | |
| 7 | 00190707099480 | 140-8747 | Reveal® Clear Aligners | NXC | Aligner, sequential | 2 | Reveal® Aligners | |
| 8 | 00190707090548 | 133-AL54 | Risas Reveal® Aligners | NXC | Aligner, sequential | 2 | Risas Reveal® Aligners | |
| 9 | 00190707070533 | 901-014-10 | Elite®.018 ROTH U7L MINI DB | DZD | TUBE, ORTHODONTIC | 1 | Elite® Bondable Buccal Tubes | |
| 10 | 00190707060541 | 100-757 | .012 x .045 Nitanium® Open Coil Spring -15" Spooled | ECO | SPRING, ORTHODONTIC | 1 | NITANIUM® ARCHWIRE SPRINGS | |
| 11 | 00190707060534 | 100-756 | .010 x .045 Nitanium® Open Coil Spring -15" Spooled | ECO | SPRING, ORTHODONTIC | 1 | NITANIUM® ARCHWIRE SPRINGS | |
| 12 | 00190707060527 | 100-755 | .014 x .036 Nitanium® Open Coil Spring -15" Spooled | ECO | SPRING, ORTHODONTIC | 1 | NITANIUM® ARCHWIRE SPRINGS | |
| 13 | 00190707060510 | 100-754 | .010 x .036 Nitanium® Open Coil Spring -15" Spooled | ECO | SPRING, ORTHODONTIC | 1 | NITANIUM® ARCHWIRE SPRINGS | |
| 14 | 00190707060503 | 100-753 | .014 x .030 Nitanium® Open Coil Spring -15" Spooled | ECO | SPRING, ORTHODONTIC | 1 | NITANIUM® ARCHWIRE SPRINGS | |
| 15 | 00190707060497 | 100-752 | .012 x .030 Nitanium® Open Coil Spring -15" Spooled | ECO | SPRING, ORTHODONTIC | 1 | NITANIUM® ARCHWIRE SPRINGS | |
| 16 | 00190707060480 | 100-751 | .010 x .030 Nitanium® Open Coil Spring -15" Spooled | ECO | SPRING, ORTHODONTIC | 1 | NITANIUM® ARCHWIRE SPRINGS | |
| 17 | 00190707060473 | 100-750 | .009 x .030 Nitanium® Open Coil Spring -15" Spooled | ECO | SPRING, ORTHODONTIC | 1 | NITANIUM® ARCHWIRE SPRINGS | |
| 18 | 00190707059262 | 424-213TI | Twin Force® Double Ended Locking Tool | JEX | PLIER, ORTHODONTIC | 1 | Twin Force® Locking Tool | |
| 19 | 00190707058067 | 777-LR4-RP | Carriere® SLX 3D™ .022 LR4 -12T 2A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 20 | 00190707058319 | 977-UR7-HK-RP | Carriere® SLX 3D™ .022 UR7 NC Std -14T 0A 10DO (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 21 | 00190707058302 | 977-UL7-HK-RP | Carriere® SLX 3D™ .022 UL7 NC Std -14T 0A 10DO (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 22 | 00190707058296 | 977-LR7-HK-RP | Carriere® SLX 3D™ .022 LR7 NC Std -10T 0A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 23 | 00190707058289 | 977-LL7-HK-RP | Carriere® SLX 3D™ .022 LL7 NC Std -10T 0A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 24 | 00190707058272 | 977-UR6-HK-RP | Carriere® SLX 3D™ .022 UR6 HK -14T 0A 12DO (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 25 | 00190707058265 | 777-UR45-HK-RP | Carriere® SLX 3D™ .022 UR4/5 HK -7T 0A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 26 | 00190707058258 | 777-UR3-HK-RP | Carriere® SLX 3D™ .022 UR3 HK 0T 9A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 27 | 00190707058241 | 777-UR3H-HK-RP | Carriere® SLX 3D™ .022 UR3 HK +7T 9A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 28 | 00190707058234 | 777-UR2H-RP | Carriere® SLX 3D™ .022 UR2 +12T 8A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 29 | 00190707058227 | 777-UR2-RP | Carriere® SLX 3D™ .022 UR2 +8T 8A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 30 | 00190707058210 | 777-UR1H-RP | Carriere® SLX 3D™ .022 UR1 +17T 5A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 31 | 00190707058203 | 777-UR1-RP | Carriere® SLX 3D™ .022 UR1 +12T 5A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 32 | 00190707058197 | 977-UL6-HK-RP | Carriere® SLX 3D™ .022 UL6 HK -14T 0A 12DO (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 33 | 00190707058180 | 777-UL45-HK-RP | Carriere® SLX 3D™ .022 UL4/5 HK -7T 0A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 34 | 00190707058173 | 777-U45-RP | Carriere® SLX 3D™ .022 U4/5 -7T 0A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 35 | 00190707058166 | 777-UL3-HK-RP | Carriere® SLX 3D™ .022 UL3 HK 0T 9A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 36 | 00190707058159 | 777-UL3H-HK-RP | Carriere® SLX 3D™ .022 UL3 HK +7T 9A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 37 | 00190707058142 | 777-UL2H-RP | Carriere® SLX 3D™ .022 UL2 +12T 8A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 38 | 00190707058135 | 777-UL2-RP | Carriere® SLX 3D™ .022 UL2 +8T 8A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 39 | 00190707058128 | 777-UL1H-RP | Carriere® SLX 3D™ .022 UL1 +17T 5A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 40 | 00190707058111 | 777-UL1-RP | Carriere® SLX 3D™ .022 UL1 +12T 5A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 41 | 00190707058104 | 977-LR6-HK-RP | Carriere® SLX 3D™ .022 LR6 HK -25T 0A 2DO (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 42 | 00190707058098 | 777-LR5-HK-RP | Carriere® SLX 3D™ .022 LR5 HK -17T 2A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 43 | 00190707058081 | 777-LR5-RP | Carriere® SLX 3D™ .022 LR5 -17T 2A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 44 | 00190707058074 | 777-LR4-HK-RP | Carriere® SLX 3D™ .022 LR4 HK -12T 2A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 45 | 00190707058050 | 777-LR3L-HK-RP | Carriere® SLX 3D™ .022 LR3 HK -6T 5A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 46 | 00190707058043 | 777-LR3-HK-RP | Carriere® SLX 3D™ .022 LR3 HK 0T 5A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 47 | 00190707058036 | 977-LL6-HK-RP | Carriere® SLX 3D™ .022 LL6 HK -25T 0A 2DO (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 48 | 00190707058029 | 777-LL5-HK-RP | Carriere® SLX 3D™ .022 LL5 HK -17T 2A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 49 | 00190707058012 | 777-LL5-RP | Carriere® SLX 3D™ .022 LL5 -17T 2A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ | |
| 50 | 00190707058005 | 777-LL4-HK-RP | Carriere® SLX 3D™ .022 LL4 HK -12T 2A 0O (RP) | EJF | BRACKET, METAL, ORTHODONTIC | 1 | Carriere® SLX 3D™ |
| 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 |