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Renamel® NANO™+plus Body C4
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6005C4Model Dental Composites and Accessories - Dental composites => Hybrid filled Composites
Identity
- Trade Name
- Renamel® NANO™+plus Body C4 EUDAMEDRenamel® NANO™ +plus FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel® NANO™ +plus Body C4, Syringe 5g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Hybrid filled Composites EUDAMED6005C4 EUDAMEDFDA UDI
- Description
- Renamel® NANO™ +plus Body C4, Syringe 5g FDA UDI
Identifiers
- Catalog Number
- 6005C4 FDA UDI
- Primary DI / UDI-DI
- +EDEL6005C40 EUDAMEDEDEL6005C40 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI050024H9 EUDAMED
- Direct Marketing DI
- +EDEL6005C40 EUDAMED
- 510(k) Number
- K163480 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® NANO™+plus Body C4 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 7c01dba2-177a-4a12-9e00-e1d99a237d7c 61 fields · synced Jul 10, 2026
- FDA UDI 201bc651-48b3-4fb5-a423-17097a2d7ba1 36 fields · synced May 30, 2026