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Renamel® Flowable Microhybrid Body B3
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 7011B3Model Dental Composites and Accessories - Dental composites => Hybrid filled Composites
Identity
- Trade Name
- Renamel® Flowable Microhybrid Body B3 EUDAMEDRenamel® Flowable Microhybrid FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel® Flowable Microhybrid Body B3, Syringe 3g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Hybrid filled Composites EUDAMED7011B3 EUDAMEDFDA UDI
- Description
- Renamel® Flowable Microhybrid Body B3, Syringe 3g FDA UDI
Identifiers
- Catalog Number
- 7011B3 FDA UDI
- Primary DI / UDI-DI
- +EDEL7011B30 EUDAMEDEDEL7011B30 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI050024H9 EUDAMED
- Direct Marketing DI
- +EDEL7011B30 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® Flowable Microhybrid Body B3 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 405f3d33-a324-4491-99d2-bb08b205f691 61 fields · synced Jun 18, 2026
- FDA UDI 6a1ea2e1-0d28-4a91-825e-27a1762883fc 36 fields · synced May 30, 2026