Identity
- Trade Name
- GUTTA PERCHA POINTS FDA UDI
- Generic Name
- Natural gutta-percha FDA UDI
- Device Name
- Gutta Percha Points is used to root canal filing material. FDA UDI
- Model / Reference
- ACCESSORY ASST(F,M) FDA UDI
- Description
- Gutta Percha Points is used to root canal filing material. FDA UDI
Identifiers
- Catalog Number
- 171-392 FDA UDI
- Primary DI / UDI-DI
- 08806383549615 FDA UDI
- FDA Product Code
- EKM FDA UDI
- GMDN Term
- Natural gutta-percha 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Natural gutta-percha
Gutta Percha Points by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Natural gutta-percha.
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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
- DiaDent Group International
Sources (1)
- FDA UDI bc932219-6791-45cb-be59-378db7150d9f 35 fields · synced May 30, 2026