Identity
- Trade Name
- SDC Aligners-REP FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- REPLACEMENT ALIGNERS FDA UDI
- Model / Reference
- 100-0355 FDA UDI
- Description
- REPLACEMENT ALIGNERS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850007728298 FDA UDI
- 510(k) Number
- K212496 FDA UDI
- FDA Product Code
- NXC FDA UDI
- GMDN Term
- Orthodontic progressive aligner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Orthodontic progressive aligner
SDC Aligners-REP by Access Dental Lab, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic progressive aligner.
- Risas Reveal® — Ortho Organizers, Inc. · Class II
- Reveal® Aligners — Ortho Organizers, Inc. · Class II
- SLX® Clear Aligners — Ortho Organizers, Inc. · Class II
- Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
- 3M™ Clarity™ — 3M UNITEK CORPORATION · Class II
- Risas Reveal Aligners — Ortho Organizers, Inc. · Class II
- Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
- Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
Cleared under the same submission
K212496 also covers:
- NIGHTTIME -REP — Access Dental Lab, LLC
- NIGHTTIME ALIGNERS - REF — Access Dental Lab, LLC
- NIGHTTIME ALIGNERS-MCC — Access Dental Lab, LLC
- NIGHTTIME CLEAR ALIGNERS — Access Dental Lab, LLC
- SDC ALIGNERS MCC — Access Dental Lab, LLC
- SDC Aligners- — Access Dental Lab, LLC
- SDC Aligners-REF — Access Dental Lab, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Access Dental Lab, LLC
Sources (1)
- FDA UDI 02fd3214-7f55-429c-ae9a-02fa58f3a37b 34 fields · synced May 30, 2026