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MAX Restorative Pins Bulk Kit Blue, .017 '' / .425 mm, 60 pcs
EUDAMEDClass IIa (EU MDR)
Ref M63
Identity
- Trade Name
- MAX Restorative Pins Bulk Kit Blue, .017 '' / .425 mm, 60 pcs EUDAMED
- Device Name
- MAX Pins EUDAMED
- Model / Reference
- M63 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D661M631 EUDAMED
- Basic UDI-DI
- B-D661M631 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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, ceramic
MAX Restorative Pins Bulk Kit Blue, .017 '' / .425 mm, 60 pcs by Coltene/Whaledent Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D661M631 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (1)
- EUDAMED 16838d35-d9ef-412f-b2a6-8794318e7a5e 61 fields · synced Jun 19, 2026