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Enamelize™
EUDAMEDFDA UDIClass I (EU MDR)
Ref 906101Model Dental Composites and Accessories - Acessories
Identity
- Trade Name
- Enamelize™ EUDAMEDFDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Dental polishing paste EUDAMEDEnamelize™, Tube 36g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Acessories EUDAMED906101 EUDAMEDFDA UDI
- Description
- Enamelize™, Tube 36g FDA UDI
Identifiers
- Catalog Number
- 906101 FDA UDI
- Primary DI / UDI-DI
- +EDEL9061010 EUDAMEDEDEL9061010 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI070031HU EUDAMED
- Direct Marketing DI
- +EDEL9061010 EUDAMED
- 510(k) Number
- K862912 FDA UDI
- FDA Product Code
- EJR FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dentifrice FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Enamelize™ by DeltaMed GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EDELTD03BUDI070031HU | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++EDELTD03BUDI070031HU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (2)
- EUDAMED ddb8e5ab-4847-4809-b9fa-d867c3e8ed3f 61 fields · synced May 31, 2026
- FDA UDI a6d93206-120a-46d1-b7d1-98ae6a7140dd 36 fields · synced May 30, 2026