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Enamel Plus Temp ®
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref TEMPUD1Model TEMP
by Micerium Spa
Identity
- Trade Name
- Enamel Plus Temp ® FDA UDI
- Generic Name
- Dental acrylic resin FDA UDI
- Device Name
- Enamel Plus Temp UD1 FDA UDI
- Model / Reference
- TEMPUD1 EUDAMEDFDA UDITEMP EUDAMED
- Description
- Enamel Plus Temp UD1 FDA UDI
Identifiers
- Catalog Number
- TEMPUD1 FDA UDI
- Primary DI / UDI-DI
- EMICTEMPUD11 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM439 EUDAMED
- 510(k) Number
- K103474 FDA UDI
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental acrylic resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 400 Gram FDA UDI
Category: Dental acrylic resin
Enamel Plus Temp ® by Micerium Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental acrylic resin.
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Cleared under the same submission
K103474 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micerium Spa
Sources (2)
- FDA UDI c1f5f586-03bb-4c4d-b5a2-62bc7817cd87 37 fields · synced Jul 19, 2026
- EUDAMED 39513fa7-e1b3-4d95-a623-110507d6352d 61 fields · synced Jul 19, 2026