Identity
- Trade Name
- MM MARKED 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 XF FDA UDI
- Description
- Gutta Percha Points is used to root canal filing material. FDA UDI
Identifiers
- Catalog Number
- ML102-S601 FDA UDI
- Primary DI / UDI-DI
- 08806383527552 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
Mm Marked Gutta Percha Points by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Natural gutta-percha.
- SSW ENDO — SS White Burs LLC · Class I
- DCTAPER — SS White Burs LLC · Class I
- Top Quality Manufacturing — TOP QUALITY MANUFACTURING, INC. · Class I
- GuttaCore Obturator — TULSA DENTAL PRODUCTS LLC · Class I
- Patterson — PATTERSON DENTAL SUPPLY, INC. · Class I
- DCTAPER — SS White Burs LLC · Class I
- EndoREZ Points — ULTRADENT PRODUCTS, INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · 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
- DiaDent Group International
Sources (1)
- FDA UDI a6d7fa26-42bf-46a2-9b8c-28061934df62 35 fields · synced May 30, 2026