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COSMESEAL™ Filled
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 61710WModel Dental Composites and Accessories - Dental composites => Microfilled Composites
Identity
- Trade Name
- COSMESEAL™ Filled EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- COSMESEAL® Filled, Syringe 1g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Dental composites => Microfilled Composites EUDAMED61710W EUDAMEDFDA UDI
- Description
- COSMESEAL® Filled, Syringe 1g FDA UDI
Identifiers
- Catalog Number
- 61710W FDA UDI
- Primary DI / UDI-DI
- +EDEL61710W0 EUDAMEDEDEL61710W0 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI040023GU EUDAMED
- Direct Marketing DI
- +EDEL61710W0 EUDAMED
- 510(k) Number
- K042823 FDA UDI
- FDA Product Code
- EBC 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
- 872.3765 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
COSMESEAL™ Filled 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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- Llis — Dentscare Ltda · Class II
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- 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 |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (2)
- EUDAMED 866a6480-2009-45ab-af28-61e29d2a7dad 61 fields · synced Jul 20, 2026
- FDA UDI c790bf70-b749-41dd-87c6-812c008db3ec 36 fields · synced May 30, 2026