Master-Dent

FDA UDI

by Dentonics, Inc.

Identity

Trade Name: MASTER-DENT FDA UDI
Generic Name: Dental etching solution FDA UDI
Device Name: Liquid Etch 240 ml Bottle (8 oz) FDA UDI
Model / Reference: 18-650-L FDA UDI
Description: Liquid Etch 240 ml Bottle (8 oz) FDA UDI

Identifiers

Primary DI / UDI-DI: 00816526020497 FDA UDI
510(k) Number: K823510 FDA UDI
GMDN Term: Dental etching solution 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 etching solution

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

Similar devices

Also classified as Dental etching solution.

Dento-Etch — Spident · Class IIa
Vivid TruEtch 10% Kit — PEARSON DENTAL SUPPLIES, INC. · Class II
DC Keramik Ätzgel — PRISMAN GmbH · Class I
OSE 8oz. Orthodontic Etching Gel - Blue — ORTHODONTIC SUPPLY & EQUIPMENT CO., INC. · Class II
ETCHANT — Pulpdent Corporation · Class II
Scotchbond™ Universal — 3M Deutschland GmbH · Class II
GC CERAMIC PRIMER II — Gc America Inc. · Class II
Etching Gel 2ml — DMP Dental Industry S.A. · Class IIa

Cleared under the same submission

K823510 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 d8d8f952-8773-4d79-b3fc-c856bbbc8ab4 35 fields · synced May 31, 2026