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3Delta Etemp A2
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1611020Model Dental Composites and Accessories - Temporary Materials
Identity
- Trade Name
- 3Delta Etemp A2 EUDAMED3Delta Etemp FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- 3Delta Etemp A2, 1000g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Temporary Materials EUDAMED1611020 EUDAMEDFDA UDI
- Description
- 3Delta Etemp A2, 1000g FDA UDI
Identifiers
- Catalog Number
- 1611020 FDA UDI
- Primary DI / UDI-DI
- +EDEL16110200 EUDAMEDEDEL16110200 FDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI030022GF EUDAMED
- Direct Marketing DI
- +EDEL16110200 EUDAMED
- 510(k) Number
- K200039 FDA UDI
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 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
No
FDA UDI
Category: Dental composite resin
3Delta Etemp A2 by DeltaMed GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | ++EDELTD03BUDI030022GF | 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 c708e6ac-fc4b-4fec-9c6f-342c419eeea8 61 fields · synced Jul 15, 2026
- FDA UDI 391a9047-2cb7-464c-a1e3-636a1db30129 36 fields · synced May 29, 2026