Master-Dent

FDA UDI

by Dentonics, Inc.

Identity

Trade Name: MASTER-DENT FDA UDI
Generic Name: Endodontic filling/sealing material FDA UDI
Device Name: Root Canal Sealer Kit, 6 ml liquid FDA UDI
Model / Reference: 12-677 FDA UDI
Description: Root Canal Sealer Kit, 6 ml liquid FDA UDI

Identifiers

Primary DI / UDI-DI: 00816526021623 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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 d668b567-a39e-4a43-aa1e-900d95af81b3 35 fields · synced Jun 8, 2026