Identity
- Trade Name
- Alpine SL FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Alpine SL Clear ROTH 022R MX CUSP 11A 0T 4MO HK FDA UDI
- Model / Reference
- Q12406 FDA UDI
- Description
- Alpine SL Clear ROTH 022R MX CUSP 11A 0T 4MO HK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885797695666 FDA UDI
- FDA Product Code
- NJM FDA UDI
- GMDN Term
- Orthodontic bracket, ceramic 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
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
Category: Orthodontic bracket, ceramic
Alpine SL by Rmo — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, ceramic.
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- APC™ II Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
- EXPERIENCE® — GC Orthodontics America Inc. · Class II
- APC™ PLUS Clarity™ SL — 3M UNITEK CORPORATION · 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
- Rmo
Sources (1)
- FDA UDI 8fe1da47-d6b5-4afa-96ce-43419d16494e 33 fields · synced May 31, 2026