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Renamel® Flowable Microfill Body D2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3011D2Model Dental Composites and Accessories - Dental composites => Microfilled Composites
Identity
- Trade Name
- Renamel® Flowable Microfill Body D2 EUDAMEDRenamel® Flowable Microfill FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel® Flowable Microfill Body D2, Syringe 3g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Microfilled Composites EUDAMED3011D2 EUDAMEDFDA UDI
- Description
- Renamel® Flowable Microfill Body D2, Syringe 3g FDA UDI
Identifiers
- Catalog Number
- 3011D2 FDA UDI
- Primary DI / UDI-DI
- +EDEL3011D20 EUDAMEDEDEL3011D20 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI040023GU EUDAMED
- Direct Marketing DI
- +EDEL3011D20 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
Category: Dental composite resin
Renamel® Flowable Microfill Body D2 by DeltaMed GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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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 94dc8138-1eaa-4b6a-82a1-e7b01981aa5e 61 fields · synced Jul 27, 2026
- FDA UDI 22d18a12-953b-45cf-8647-9159380053fc 36 fields · synced May 30, 2026