Identity
- Trade Name
- GIBSON HEALTHCARE FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Gibson Healthcare MTA BioCeramic Root Canal Sealer 9G Syringe FDA UDI
- Model / Reference
- 5245-601 FDA UDI
- Description
- Gibson Healthcare MTA BioCeramic Root Canal Sealer 9G Syringe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00366975012210 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic filling/sealing material
Gibson Healthcare by Benco Dental Supply Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- DIA-ROOT BIO Sealer — DiaDent Group International · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Benco Dental Supply Co.
Sources (1)
- FDA UDI 9101afb9-db4b-4c85-980c-bb309b57a218 34 fields · synced Jun 6, 2026