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Renamel® Microhybrid SuperBrite 2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 613SB2Model Dental Composites and Accessories - Dental composites => Hybrid filled Composites
Identity
- Trade Name
- Renamel® Microhybrid SuperBrite 2 EUDAMEDRenamel® Microhybrid FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel® Microhybrid SuperBrite 2, Syringe 5g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Hybrid filled Composites EUDAMED613SB2 EUDAMEDFDA UDI
- Description
- Renamel® Microhybrid SuperBrite 2, Syringe 5g FDA UDI
Identifiers
- Catalog Number
- 613SB2 FDA UDI
- Primary DI / UDI-DI
- +EDEL613SB20 EUDAMEDEDEL613SB20 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI050024H9 EUDAMED
- Direct Marketing DI
- +EDEL613SB20 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
Renamel® Microhybrid SuperBrite 2 by DeltaMed GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 b745ff82-6a00-4e57-b255-ed2a9b07d6a2 61 fields · synced Jun 18, 2026
- FDA UDI e2b8d6ba-6942-4441-a658-078a5f83611d 36 fields · synced May 30, 2026