← Back to catalogue
Renamel® Microfill Enamel Body B4
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6071B4Model Dental Composites and Accessories - Dental composites => Microfilled Composites
Identity
- Trade Name
- Renamel® Microfill Enamel Body B4 EUDAMEDRenamel® Microfill FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel® Microfill Enamel Body B4, Syringe 4g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Microfilled Composites EUDAMED6071B4 EUDAMEDFDA UDI
- Description
- Renamel® Microfill Enamel Body B4, Syringe 4g FDA UDI
Identifiers
- Catalog Number
- 6071B4 FDA UDI
- Primary DI / UDI-DI
- +EDEL6071B40 EUDAMEDEDEL6071B40 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI040023GU EUDAMED
- Direct Marketing DI
- +EDEL6071B40 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 Body B4 by DeltaMed GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
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 cc832d7e-8f50-4579-866c-ba28d4f1788e 61 fields · synced Jul 26, 2026
- FDA UDI 75ef2794-6b62-4bdb-8742-22237f5afff0 36 fields · synced May 30, 2026