← Back to catalogue
Renamel® Flowable Microfill Body B2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3011B2Model Dental Composites and Accessories - Dental composites => Microfilled Composites
Identity
- Trade Name
- Renamel® Flowable Microfill Body B2 EUDAMEDRenamel® Flowable Microfill FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel® Flowable Microfill Body B2, Syringe 3g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Microfilled Composites EUDAMED3011B2 EUDAMEDFDA UDI
- Description
- Renamel® Flowable Microfill Body B2, Syringe 3g FDA UDI
Identifiers
- Catalog Number
- 3011B2 FDA UDI
- Primary DI / UDI-DI
- +EDEL3011B20 EUDAMEDEDEL3011B20 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI040023GU EUDAMED
- Direct Marketing DI
- +EDEL3011B20 EUDAMED
- 510(k) Number
- K974494 FDA UDI
- FDA Product Code
- EBD 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
- 872.3310 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® Flowable Microfill Body B2 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 | ++EDELTD03BUDI040023GU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (2)
- EUDAMED ba9737a5-e368-4a74-9d17-7e96398c748e 61 fields · synced Jul 18, 2026
- FDA UDI ed066148-6164-455d-ba33-740ad505edf7 36 fields · synced May 30, 2026