Identity
- Trade Name
- CB Temp A2 FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- CB Temp Temporary Crown & Bridge Material shade A2 FDA UDI
- Model / Reference
- 28600100 FDA UDI
- Description
- CB Temp Temporary Crown & Bridge Material shade A2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10852253006226 FDA UDI
- 510(k) Number
- K020157 FDA UDI
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Temporary dental crown/bridge resin
CB Temp A2 by J. Morita U.s.a., Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Temporary dental crown/bridge resin.
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- DENTURE BASE — AMERICAN TOOTH INDUSTRIES · Class II
- PORTUX CAD/CAM Disc. 98.5X 25mm C2. MN — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- tempofit premium BL — DETAX GmbH · Class II
- YAMAHACHI PMMA DISK — YAMAHACHI DENTAL MFG., CO. · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- J. Morita U.s.a., Inc
Sources (1)
- FDA UDI d9f1cfca-5b52-4c32-950a-542fbf3b3bcc 34 fields · synced May 31, 2026