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Renamel® Microhybrid Body A2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6061A2Model Dental Composites and Accessories - Dental composites => Hybrid filled Composites
Identity
- Trade Name
- Renamel® Microhybrid Body A2 EUDAMEDRenamel® Microhybrid FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel® Microhybrid Body A2, Syringe 5g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Hybrid filled Composites EUDAMED6061A2 EUDAMEDFDA UDI
- Description
- Renamel® Microhybrid Body A2, Syringe 5g FDA UDI
Identifiers
- Catalog Number
- 6061A2 FDA UDI
- Primary DI / UDI-DI
- +EDEL6061A20 EUDAMEDEDEL6061A20 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI050024H9 EUDAMED
- Direct Marketing DI
- +EDEL6061A20 EUDAMED
- 510(k) Number
- K222435 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 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
Yes
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
Category: Dental composite resin
Renamel® Microhybrid Body A2 by DeltaMed GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EDELTD03BUDI050024H9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (2)
- EUDAMED d2e10f12-aaa8-4ec6-ad78-6e58acabf350 61 fields · synced Jul 19, 2026
- FDA UDI aa0316f4-a5b9-4fc1-bca2-d3a758723469 36 fields · synced May 30, 2026