Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Henry Schein FDA UDI
Generic Name: Dental etching solution FDA UDI
Device Name: Etch Gel Syringe Kit 40% FDA UDI
Model / Reference: 1015396 FDA UDI
Description: Etch Gel Syringe Kit 40% FDA UDI

Identifiers

Catalog Number: 1015396 FDA UDI
Primary DI / UDI-DI: 00304040005804 FDA UDI
FDA Product Code: KLE FDA UDI
GMDN Term: Dental etching solution FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
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

Yes

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

Dimensions & Sizes

Size: Total Volume — 1.2 Milliliter FDA UDI
Needle Gauge — 22 Gauge FDA UDI

Category: Dental etching solution

Henry Schein by Henry Schein, Inc. — Class II — 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
MASTER-DENT — DENTONICS, INC.
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

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: Henry Schein, Inc.

Sources (1)

FDA UDI 0a6648d0-3631-4707-ae67-90eb13a192d3 36 fields · synced May 30, 2026