Identity
- Trade Name
- Powerresin C-Temp Resin 125 g Bleach EUDAMED
- Device Name
- Powerresins C-Temp Resin EUDAMED
- Model / Reference
- PCT-04-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684508853621 EUDAMED
- Basic UDI-DI
- 8684508853PCTMU EUDAMED
- Direct Marketing DI
- 08684508853621 EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental appliance fabrication material, resin
Powerresin C-Temp Resin 125 g Bleach by 3bfab Teknoloji Anonim Şirketi — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8684508853PCTMU | Class I | Active |
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Manufacturer
- Manufacturer
- 3bfab Teknoloji Anonim Şirketi
- EUDAMED SRN
- TR-MF-000040768
Sources (1)
- EUDAMED 8e0bb883-a43c-4b8e-abe0-a67fcb2644d8 61 fields · synced Oct 7, 2026