Identity
- Trade Name
- Reveal® Clear Aligners FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- Reveal® Clear Aligners FDA UDI
- Model / Reference
- 140-8799 FDA UDI
- Description
- Reveal® Clear Aligners FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707099909 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Category: Orthodontic progressive aligner
Reveal® Clear Aligners by Ortho Organizers, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic progressive aligner.
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- 3M™ Clarity™ — 3M UNITEK CORPORATION · Class II
- Clear Image Aligner Plus (Z-FLX): Upper — SPECIALTY APPLIANCES, LLC · Class II
- Clear Image Aligner Plus (Z-FLX): Lower — SPECIALTY APPLIANCES, LLC · Class II
- Clear Image Aligner — SPECIALTY APPLIANCES, LLC · Class II
- Reveal™ Aligners — HENRY SCHEIN, 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
- Ortho Organizers, Inc.
Sources (1)
- FDA UDI 073b3f4d-0b9b-4855-837e-401d48dc4ad0 33 fields · synced Jun 9, 2026