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P Pro Crown & Bridge A3
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 019.3068Model Dental Composites and Accessories - Temporary Materials
Identity
- Trade Name
- P Pro Crown & Bridge A3 EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- P pro Crown & Bridge A3 1000g FDA UDI
- Model / Reference
- Dental Composites and Accessories - Temporary Materials EUDAMED019.3068 EUDAMEDFDA UDI
- Description
- P pro Crown & Bridge A3 1000g FDA UDI
Identifiers
- Catalog Number
- 019.3068 FDA UDI
- Primary DI / UDI-DI
- 04260635980320 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EDELTD03BUDI030022GF EUDAMED
- Direct Marketing DI
- 04260635980320 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
Yes
FDA UDI
Category: Dental composite resin
P Pro Crown & Bridge A3 by DeltaMed GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200039 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++EDELTD03BUDI030022GF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Deltamed GmbH
- EUDAMED SRN
- DE-MF-000007882
Sources (3)
- EUDAMED 2f7c6eee-df50-443d-b2b9-e6ff919ba730 61 fields · synced Jul 24, 2026
- FDA UDI 1e537a9d-eba9-40d1-8bb3-17a921acb2b0 36 fields · synced May 30, 2026
- FDA 510(k) K200039 1 fields · synced May 18, 2026