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Renamel® Flowable Microhybrid Medium Incisal
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 7011MIModel Dental Composites and Accessories - Dental composites => Hybrid filled Composites
Identity
- Trade Name
- Renamel® Flowable Microhybrid Medium Incisal EUDAMEDRenamel® Flowable Microhybrid FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Renamel® Flowable Microhybrid Medium Incisal, Syringe 3g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Hybrid filled Composites EUDAMED7011MI EUDAMEDFDA UDI
- Description
- Renamel® Flowable Microhybrid Medium Incisal, Syringe 3g FDA UDI
Identifiers
- Catalog Number
- 7011MI FDA UDI
- Primary DI / UDI-DI
- +EDEL7011MI0 EUDAMEDEDEL7011MI0 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI050024H9 EUDAMED
- Direct Marketing DI
- +EDEL7011MI0 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
Category: Dental composite resin
Renamel® Flowable Microhybrid Medium Incisal 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 | ++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 97ac8b8f-8a50-40f9-bf80-510b86d94b15 61 fields · synced Jul 12, 2026
- FDA UDI 17add3a9-f75f-4f89-ba1f-28d2357fe687 36 fields · synced May 30, 2026