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Renamel® Microfill Enamel Light Opaque
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6071LOModel Dental Composites and Accessories - Dental composites => Microfilled Composites
Identity
- Trade Name
- Renamel® Microfill Enamel Light Opaque EUDAMEDRenamel® Microfill FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel® Microfill Enamel Light Opaque, Syringe 4g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Microfilled Composites EUDAMED6071LO EUDAMEDFDA UDI
- Description
- Renamel® Microfill Enamel Light Opaque, Syringe 4g FDA UDI
Identifiers
- Catalog Number
- 6071LO FDA UDI
- Primary DI / UDI-DI
- +EDEL6071LO0 EUDAMEDEDEL6071LO0 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI040023GU EUDAMED
- Direct Marketing DI
- +EDEL6071LO0 EUDAMED
- 510(k) Number
- K172707 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® Microfill Enamel Light Opaque 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 | ++EDELTD03BUDI040023GU | 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 0616f340-c703-4c20-8d97-f59a3dc161a0 61 fields · synced Jun 20, 2026
- FDA UDI c37f3ea1-b2e0-400e-b746-175d06c6002b 36 fields · synced May 30, 2026