No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850004223987 | ITISK00001 | Refinement Impression Kit (Medium Trays)Kett PuttyDigital | ELW,EHY,EIG | Material, Impression,Tray, Impression, Preformed,Retractor, All Types | 1 | Candid Refinement Impression Kit | |
2 | 00850004223789 | FGS-0009 | Impression Kit (Medium Trays)Zest PuttyDigital | ELW,EHY,EIG | Material, Impression,Tray, Impression, Preformed,Retractor, All Types | 1 | Candid Impression Kit | |
3 | 00850004223567 | FA-0001 | Candid Aligner System FA-0001 | NXC | Aligner, Sequential | 2 | Candid Aligner | |
4 | 00850004223345 | FGS-0010 | Candid finished impression kit (New Light Blue Tray + Kett Putty + Digital) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Impression Kit | |
5 | 00850004223185 | IKDIGITAL00004 | Candid finished impression kit (Old Tray + Kett Putty + Digital) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Impression Kit | |
6 | 00850004223178 | IKMIXFINISHED00001 | Candid finished impression kit (Mesh Impression Tray Low + Reg Impression Tray Up) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Impression Kit | |
7 | 00850004223161 | IKDIGITAL00003 | Candid finished impression kit (Old Tray + Kulz Putty + Digital) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Impression Kit | |
8 | 00850004223123 | IKDIGITAL00002 | Candid finished impression kit (Old Tray + Kett Putty + Digital) | ELW,EHY,EIG | Material, Impression,Tray, Impression, Preformed,Retractor, All Types | 1 | Candid Impression Kit | |
9 | 00850004223116 | IKMESHFINISHED00002 | Candid finished impression kit (Mesh Impression Tray + Kett Putty) | ELW,EHY,EIG | Material, Impression,Tray, Impression, Preformed,Retractor, All Types | 1 | Candid Impression Kit | |
10 | 00850004223109 | IKMESHFINISHED00001 | Candid finished impression kit (Mesh Impression Tray) | ELW,EHY,EIG | Material, Impression,Tray, Impression, Preformed,Retractor, All Types | 1 | Candid Impression Kit | |
11 | 00850004223024 | IKHELLO00001 | August 2020 Promo | EIG,EHY,ELW,JES | Retractor, All Types,Tray, Impression, Preformed,Material, Impression,Floss, Dental | 1 | Candid Impression Kit | |
12 | 00850004223017 | IKFINISHED00002 | Candid finished impression kit | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Impression Kit | |
13 | 00850004223000 | IKDIGITAL00005 | Candid finished impression kit (Old Tray + Kett Putty + Digital+toothbrush) | EIG,EHY,ELW,EFW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression,Toothbrush, Manual | 1 | Candid Impression Kit | |
14 | 08500042230004 | FA-0001 | Candid Aligner System FA-0001 | NXC | Aligner, Sequential | 2 | Candid Aligner | |
15 | 00850004223154 | RDKETTL0001 | Redo Impression Kit (Large Trays)Kett PuttyDigital | ELW,EHY,EIG | Material, Impression,Tray, Impression, Preformed,Retractor, All Types | 1 | Candid Redo Impression Kit | |
16 | 00850004223147 | RDKETTM0001 | Redo Impression Kit (Medium Trays)Kett PuttyDigital | ELW,EHY,EIG | Material, Impression,Tray, Impression, Preformed,Retractor, All Types | 1 | Candid Redo Impression Kit | |
17 | 00850004223130 | RDKETTS0001 | Redo Impression Kit (Small Trays)Kett PuttyDigital | ELW,EHY,EIG | Material, Impression,Tray, Impression, Preformed,Retractor, All Types | 1 | Candid Redo Impression Kit | |
18 | 00850004223093 | URBD0004 | Redo Impression Kit (small Trays) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Redo Impression Kit | |
19 | 00850004223086 | UBRD0002 | Redo Impression Kit (medium trays) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Redo Impression Kit | |
20 | 00850004223079 | RDLGORANGE00001 | Redo Impression Kit (large trays) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Redo Impression Kit | |
21 | 00850004223062 | RDMDORANGE00001 | Candid redo impression (medium trays) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Redo Impression Kit | |
22 | 00850004223055 | RDMDPAT00001 | Redo Impression Kit RDMDPAT00001 (Medium Trays) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Redo Impression Kit | |
23 | 00850004223048 | RDSMORANGE00001 | Candid Redo Impression Kit (small trays) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Redo Impression Kit | |
24 | 00850004223031 | URBD0003 | Redo Impression Kit (Large Trays) | EIG,EHY,ELW | Retractor, All Types,Tray, Impression, Preformed,Material, Impression | 1 | Candid Redo Impression Kit |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 03770020010088 | Reproduction Aligner | ALIGN_REPRO | Smilers | BIOTECH DENTAL SMILERS | |
2 | 03770020010071 | Reproduction Aligner | ALIGN_REPRO | Smilers | BIOTECH DENTAL SMILERS | |
3 | 03770020010064 | Retainer Appliance | GOUTC | GOUTC for 2 archs | Smilers | BIOTECH DENTAL SMILERS |
4 | 03770020010057 | Retainer Appliance | GOUTC | GOUTC for 1 arch | Smilers | BIOTECH DENTAL SMILERS |
5 | 03770020010040 | Passive Appliance | GOUTPA | Smilers | BIOTECH DENTAL SMILERS | |
6 | 03770020010033 | Attachement placement aligner | GOUTP | GOUTP for 2 archs | Smilers | BIOTECH DENTAL SMILERS |
7 | 03770020010026 | Attachement placement aligner | GOUTP | GOUP for 1 arch | Smilers | BIOTECH DENTAL SMILERS |
8 | 03770020010019 | Aligner | ALIGNEURS | aligners for 2 archs | Smilers | BIOTECH DENTAL SMILERS |
9 | 03770020010002 | Aligner | ALIGNEURS | aligner for 1 arch | Smilers | BIOTECH DENTAL SMILERS |
10 | 00889989084870 | 728-3033 | Spark Advanced - Reorder | Spark | ORMCO CORPORATION | |
11 | 00889989084863 | 728-3032 | Spark Advanced - Refinement | Spark | ORMCO CORPORATION | |
12 | 00889989084856 | 728-3031 | Spark Advanced - Single Arch | Spark | ORMCO CORPORATION | |
13 | 00889989084849 | 728-3023 | Spark 20 / Active - Reorder | Spark | ORMCO CORPORATION | |
14 | 00889989084832 | 728-3022 | Spark 20 / Active - Refinement | Spark | ORMCO CORPORATION | |
15 | 00889989084825 | 728-3021 | Spark 20 / Active - Single Arch | Spark | ORMCO CORPORATION | |
16 | 00889989084818 | 728-3013 | Spark 10 / Apt - Reorder | Spark | ORMCO CORPORATION | |
17 | 00889989084801 | 728-3012 | Spark 10 / Apt - Refinement | Spark | ORMCO CORPORATION | |
18 | 00889989084795 | 728-3011 | Spark 10 / Apt - Single Arch | Spark | ORMCO CORPORATION | |
19 | 00889989083460 | 728-3030 | Spark Advanced - Dual Arch | Spark | ORMCO CORPORATION | |
20 | 00889989083453 | 728-3020 | Spark 20 / Active - Dual Arch | Spark | ORMCO CORPORATION | |
21 | 00889989083446 | 728-3010 | Spark 10 / Apt - Dual Arch | Spark | ORMCO CORPORATION | |
22 | 00889989061987 | 3000-0006 | Set of clear plastic aligners – corrects minor to intermediate anterior malalign Set of clear plastic aligners – corrects minor to intermediate anterior malalignments of teeth | Clearguide Express | ALLESEE AOA-PRO | |
23 | 00889989061918 | 3000-0005 | Set of clear plastic aligners – corrects minor to intermediate anterior malalign Set of clear plastic aligners – corrects minor to intermediate anterior malalignments of teeth | Simpli5 | ALLESEE AOA-PRO | |
24 | 00889989061901 | 3000-0004 | Set of clear plastic aligners – corrects minor to intermediate anterior malalign Set of clear plastic aligners – corrects minor to intermediate anterior malalignments of teeth | Red, White and Blue Retainer | ALLESEE AOA-PRO | |
25 | 00860006891206 | K173785 | Dandy Clear Aligners | ORTHLY, INC. | ||
26 | 00860006274368 | TSCA | Tru-Smile Clear Aligner | Tru-Smile | PHASE ORTHO, INC. | |
27 | 00860006274344 | PLCA | Phase Ortho Private Label Clear Aligner - Temporary Placeholder | Phase Ortho Private Label | PHASE ORTHO, INC. | |
28 | 00860006274320 | SSCA | Smile Shapers Clear Aligner - Zendura | Smile Shapers | PHASE ORTHO, INC. | |
29 | 00860006274306 | POCA | Phase Ortho Clear Aligner | Phase Ortho | PHASE ORTHO, INC. | |
30 | 00860005619016 | X | Clear Dental Aligner | Straight T Clear Dental Aligner | STRAIGHT-T LLC | |
31 | 00860003321751 | RA1 | OrthoFX Rescue aligner. Specialized purpose of bringing off track treatment back on track. | OrthoFX Rescue Aligner | ORTHOFX | |
32 | 00860003321706 | FXTetra | Updated UDI submission for Zendura material aligners. | OrthoFX | ORTHOFX | |
33 | 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. | |
34 | 00860002380063 | FG0094 Rev. D | uLab Systems Dental Aligner | ULAB SYSTEMS, INC. | ||
35 | 00860002380056 | FG0094 | uLab Systems Dental Aligner | ULAB SYSTEMS, INC. | ||
36 | 00860002302355 | POCA | Discontinued product code. | Phase Ortho | DERBY DENTAL LABORATORY, INC | |
37 | 00860002302348 | TSCA | Clear sequential aligner / progressive orthodontic appliance system. | Tru-Smile | DERBY DENTAL LABORATORY, INC | |
38 | 00860002302317 | SSCA | Discontinued product code. | Smile Shapers | DERBY DENTAL LABORATORY, INC | |
39 | 00860002302300 | 01 | Discontinued - No longer in use. | Smile Shapers, Tru-Smile | DERBY DENTAL LABORATORY, INC | |
40 | 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. | |
41 | 00860000506007 | PRS-0063 | PRS-0063 | Sequential Aligners | Byte Aligner System | STRAIGHT SMILE LLC |
42 | 00856379007276 | 1000 | ASSY-500016 | SureSmile Aligner (10 hours/day) | SureSmile® Aligner | ORAMETRIX, INC. |
43 | 00856379007085 | 7.6 | SureSmile Aligner Software | ORAMETRIX, INC. | ||
44 | 00856379007047 | 3000 | SureSmile attachment template | ORAMETRIX, INC. | ||
45 | 00856379007030 | 2000 | SureSmile attachment template | ORAMETRIX, INC. | ||
46 | 00856379007023 | 1000 | SureSmile aligner | ORAMETRIX, INC. | ||
47 | 00856379007016 | 2000 | sureclear template | ORAMETRIX, INC. | ||
48 | 00856379007009 | 1000 | sureclear aligner | ORAMETRIX, INC. | ||
49 | 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. | |
50 | 00850017524170 | NBYTETray | PRS-0063 | Sequential Aligners | Byte Night Aligners | STRAIGHT SMILE LLC |