Identity
- Trade Name
- Pindex System 1 Full Arch Mold EUDAMEDPindex FDA UDI
- Generic Name
- Dental laboratory power tool system FDA UDI
- Device Name
- Pindex Model and Die Fabrication System EUDAMED1 Full Arch Mold FDA UDI
- Model / Reference
- PX147 EUDAMEDFDA UDI
- Description
- 1 Full Arch Mold FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661PX1470 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental appliance fabrication material, ceramic
Pindex System 1 Full Arch Mold by Coltene/Whaledent Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 48376f71-c7c7-4e6c-bd0f-6d5414825cbd 61 fields · synced Jul 13, 2026
- FDA UDI b6689133-bec4-479f-90ce-7520ffb5ee67 33 fields · synced May 30, 2026