Identity
- Trade Name
- GuttaCore Obturators FDA UDI
- Generic Name
- Natural gutta-percha FDA UDI
- Device Name
- GuttaCore for RECIPROC Blue R40 FDA UDI
- Model / Reference
- TNSRBGCC00040 FDA UDI
- Description
- GuttaCore for RECIPROC Blue R40 FDA UDI
Identifiers
- Catalog Number
- TNSRBGCC00040 FDA UDI
- Primary DI / UDI-DI
- D716TNSRBGCC000401 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
GuttaCore Obturators by Tulsa Dental Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Natural gutta-percha.
- GUTTA PERCHA POINTS — DiaDent Group International · Class I
- GUTTA PERCHA POINTS — DiaDent Group International · Class I
- MM MARKED GUTTA PERCHA POINTS — DiaDent Group International · Class I
- MM MARKED GUTTA PERCHA POINTS — DiaDent Group International · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tulsa Dental Products Llc
Sources (1)
- FDA UDI 9d99f3ee-0f9d-48f9-8931-0089ad990b4e 34 fields · synced Jun 7, 2026