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tempofit premium B1
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 04315Model Colour variants
Identity
- Trade Name
- tempofit premium B1 Standardpack. EUDAMEDtempofit premium B1 FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Model / Reference
- 04315 EUDAMEDFDA UDIColour variants EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET043151 EUDAMEDEDET04315 FDA UDI
- Basic UDI-DI
- ++EDET08262 EUDAMED
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Temporary dental crown/bridge resin
tempofit premium B1 by DETAX GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Temporary dental crown/bridge resin.
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- MODIFYING STAIN — AMERICAN TOOTH INDUSTRIES · Class II
- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
Sources (2)
- FDA UDI cd8841e8-22c6-45f8-894c-f5b1bd266a8e 33 fields · synced Jul 18, 2026
- EUDAMED 64cff5b4-76c7-4462-8bb8-45b5b91ed550 61 fields · synced Jul 18, 2026