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Pindex System 100 Pindex Replacement Blades - 0.007
EUDAMEDFDA UDIClass I (EU MDR)
Ref PX301
Identity
- Trade Name
- Pindex System 100 Pindex Replacement Blades - 0.007 EUDAMEDPindex FDA UDI
- Generic Name
- Dental laboratory power tool system FDA UDI
- Device Name
- Pindex Model and Die Fabrication System EUDAMED100 Pindex Replacement Blades - .007 FDA UDI
- Model / Reference
- PX301 EUDAMEDFDA UDI
- Description
- 100 Pindex Replacement Blades - .007 FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661PX3011 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D661019KN EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental laboratory power tool system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Pindex System 100 Pindex Replacement Blades - 0.007 by Coltene/Whaledent Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | ++D661019KN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (2)
- EUDAMED c2ead50c-b67e-44b6-a702-bbaaac8552f5 61 fields · synced Jun 18, 2026
- FDA UDI 781e2020-d1ae-4131-a05d-f56cd0391361 33 fields · synced May 30, 2026