Identity
- Trade Name
- Protraction Facemask FDA UDI
- Generic Name
- Orthodontic chin cap/cup FDA UDI
- Device Name
- PROTRACTION FACE MASK FDA UDI
- Model / Reference
- 852-800 FDA UDI
- Description
- PROTRACTION FACE MASK FDA UDI
Identifiers
- Catalog Number
- 852-800 FDA UDI
- Primary DI / UDI-DI
- 00190746057946 FDA UDI
- FDA Product Code
- DZB FDA UDI
- GMDN Term
- Orthodontic chin cap/cup FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5500 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Protraction Facemask by American Orthodontics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- American Orthodontics
Sources (1)
- FDA UDI 2fbdfe59-0b25-4bd2-b2c9-41d25c95be75 36 fields · synced Jun 9, 2026