Identity
- Trade Name
- Clearly FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- Sequential clear aligner system to straighten teeth FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Sequential clear aligner system to straighten teeth FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010675700 FDA UDI
- 510(k) Number
- K212772 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic progressive aligner
Clearly by Precision Align LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
- Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
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 |
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Manufacturer
- Manufacturer
- Precision Align LLC
Sources (1)
- FDA UDI de424ede-ed4e-406b-8856-56b9670831d1 34 fields · synced Jun 8, 2026