Identity
- Trade Name
- GUTTA PERCHA POINT 2% - N°60 FDA UDI
- Generic Name
- Natural gutta-percha FDA UDI
- Device Name
- Gutta percha point is used to fill a prepared root canal prior to tooth restoration. It is used to fill the endodontic cavity to result in complete sealing in order to prevent reoccurrence of pathologies in root canal which may occur if root canal is not obturated. Box of 120 pieces - Length 28mm - Color Code: Blue FDA UDI
- Model / Reference
- 24012 FDA UDI
- Description
- Gutta percha point is used to fill a prepared root canal prior to tooth restoration. It is used to fill the endodontic cavity to result in complete sealing in order to prevent reoccurrence of pathologies in root canal which may occur if root canal is not obturated. Box of 120 pieces - Length 28mm - Color Code: Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809264293126 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Natural gutta-percha
Gutta Percha Point 2% - N°60 by Produits dentaires S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Natural gutta-percha.
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- SSW ENDO — SS White Burs LLC · Class I
- DCTAPER — SS White Burs LLC · Class I
- GUTTA PERCHA POINTS — DiaDent Group International · Class I
- GUTTA PERCHA POINTS — DiaDent Group International · Class I
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
- Produits dentaires S.A.
Sources (1)
- FDA UDI 5d482062-ea1d-4a05-815b-b39ce7967919 34 fields · synced May 30, 2026