Master-Dent

FDA UDI

by Dentonics, Inc.

Identity

Trade Name: MASTER-DENT FDA UDI
Generic Name: Dental pit/fissure sealant FDA UDI
Device Name: Pit & Fissure Sealant, 2x7ml bottles, Self Cure, Opaque, mixing pad FDA UDI
Model / Reference: 12-004 FDA UDI
Description: Pit & Fissure Sealant, 2x7ml bottles, Self Cure, Opaque, mixing pad FDA UDI

Identifiers

Catalog Number: 12-004 FDA UDI
Primary DI / UDI-DI: 00816526021432 FDA UDI
510(k) Number: K790788 FDA UDI
GMDN Term: Dental pit/fissure sealant 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: Dental pit/fissure sealant

Master-Dent by Dentonics, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental pit/fissure sealant.

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AURA — Sdi , Ltd. · Class II
GLACIER — Sdi , Ltd. · Class II
SciPharm Pit & Fissure Sealer Bonding Agent — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
Seal-Rite™ Low Viscosity — Pulpdent Corporation · Class II

Cleared under the same submission

K790788 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 4da8076d-411e-467c-b518-3e17db458bd1 36 fields · synced May 30, 2026