Identity
- Trade Name
- Powerresins C-Temp Resin 500 g-Light EUDAMED
- Device Name
- Powerresins C-Temp Resin EUDAMED
- Model / Reference
- PCT-02-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684508853195 EUDAMED
- Basic UDI-DI
- 8684508853PCTMU EUDAMED
- Direct Marketing DI
- 08684508853195 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
Powerresins C-Temp Resin 500 g-Light by 3bfab Teknoloji Anonim Şirketi — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, resin.
- O-Cryl Self Curing Acrylic Shade White X 1 lb — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- PREMIUM — Lang Dental Manufacturing Company, Inc. · Class II
- Axcent Acrylics — GARRECO, LLC · Class II
- smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
- BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
- vynacron dental resins — VYNACRON DENTAL RESINS, INC. · Class II
- HI-I® — FRICKE INTERNATIONAL, INC. · Class II
- FREEPRINT crown A1 500g — DETAX GmbH · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3bfab Teknoloji Anonim Şirketi
- EUDAMED SRN
- TR-MF-000040768
Sources (1)
- EUDAMED 47487f1d-42f6-4f72-b1b5-938d124da810 61 fields · synced Oct 6, 2026