Identity
- Trade Name
- Luna FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Luna Opal MB Mini .022 UR4,5 D/HK (-7°T 0°A) FDA UDI
- Model / Reference
- 221111 FDA UDI
- Description
- Luna Opal MB Mini .022 UR4,5 D/HK (-7°T 0°A) FDA UDI
Identifiers
- Catalog Number
- 221111 FDA UDI
- Primary DI / UDI-DI
- 00883205003973 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
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 bracket, ceramic
Luna by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ultradent Products, Inc.
Sources (1)
- FDA UDI 2d5fa8e9-cb5c-4e0a-a1ca-47265e9875bf 35 fields · synced May 31, 2026