Uni-Etch

FDA UDI

Class I (US FDA UDI)

by Bisco Inc.

Identity

Trade Name: Uni-Etch FDA UDI
Generic Name: Dental etching solution FDA UDI
Device Name: Uni-Etch (32% Phosphoric Acid Etchant) 4-Syr Pkg FDA UDI
Model / Reference: E-5502EM FDA UDI
Description: Uni-Etch (32% Phosphoric Acid Etchant) 4-Syr Pkg FDA UDI

Identifiers

Catalog Number: E-5502EM FDA UDI
Primary DI / UDI-DI: 00810111541022 FDA UDI
FDA Product Code: EID FDA UDI
KLE FDA UDI
GMDN Term: Dental etching solution FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
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

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

Yes

FDA UDI

Category: Dental etching solution

Uni-Etch by Bisco Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Bisco Inc.

Sources (1)

FDA UDI bae368ab-5a22-4d6d-9c0f-68d2832f142d 36 fields · synced May 30, 2026