Identity
- Trade Name
- HYGENIC® Guttapercha Points FDA UDI
- Generic Name
- Root canal obturating point FDA UDI
- Device Name
- HYGENIC® Guttapercha Points Top color ISO 20 FDA UDI
- Model / Reference
- H01470 FDA UDI
- Description
- HYGENIC® Guttapercha Points Top color ISO 20 FDA UDI
Identifiers
- Catalog Number
- H01470 FDA UDI
- Primary DI / UDI-DI
- 14260538370201 FDA UDI
- FDA Product Code
- EKM FDA UDI
- GMDN Term
- Root canal obturating point FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Root canal obturating point
HYGENIC® Guttapercha Points by Coltène/Whaledent AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coltène/Whaledent AG
Sources (1)
- FDA UDI a98508c2-2cb3-4d41-b1bf-2a299368cad2 36 fields · synced May 30, 2026