Identity
- Trade Name
- DIA-ROOT BIO Sealer FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials. FDA UDI
- Model / Reference
- DIA-ROOT BIO Sealer 2.0g FDA UDI
- Description
- DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials. FDA UDI
Identifiers
- Catalog Number
- 1003-701 FDA UDI
- Primary DI / UDI-DI
- 08806383565790 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic filling/sealing material
DIA-ROOT BIO Sealer by DiaDent Group International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic filling/sealing material.
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- Henry Schein — HENRY SCHEIN, INC. · Class II
- GIBSON — BENCO DENTAL SUPPLY CO. · Class II
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- 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
- DiaDent Group International
Sources (1)
- FDA UDI 7342961e-f841-41c4-ac56-c39a5659c36b 35 fields · synced May 30, 2026