Identity
- Trade Name
- MASTER-DENT FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- N-Methasone, Perm Root Canal Filling Material, Radiop, 14gm Pwd & 10ml Liq FDA UDI
- Model / Reference
- 12-685 FDA UDI
- Description
- N-Methasone, Perm Root Canal Filling Material, Radiop, 14gm Pwd & 10ml Liq FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816526021210 FDA UDI
- 510(k) Number
- K933543 FDA UDI
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Master-Dent by Dentonics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic filling/sealing material.
- ACROSEAL TUBE — SEPTODONT SAS SPECIALITES SEPTODONT · Class II
- Pulp Canal Sealer — Ormco Corporation · Class II
- ROEKO GuttaFlow®2 — Coltène/Whaledent AG · Class I
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class II
- GIBSON — BENCO DENTAL SUPPLY CO. · Class II
- Midway Select — MIDWAY DENTAL SUPPLY, LLC · Class I
- DIA-ROOT BIO Sealer — DiaDent Group International · Class II
Cleared under the same submission
K933543 also covers:
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Dentonics, Inc.
Sources (1)
- FDA UDI 4b39b80b-a7a4-4c19-a184-a9a290da6b55 35 fields · synced May 29, 2026