Epitex®

FDA UDI

Class I (US FDA UDI)

by Gc America Inc.

Identity

Trade Name: EPITEX® FDA UDI
Generic Name: Dental abrasive strip, single-use FDA UDI
Device Name: EPITEX® Refill Packages Contains: 1 Reel Medium (Green) FDA UDI
Model / Reference: 473021 FDA UDI
Description: EPITEX® Refill Packages Contains: 1 Reel Medium (Green) FDA UDI

Identifiers

Catalog Number: 473021 FDA UDI
Primary DI / UDI-DI: D6584730211 FDA UDI
FDA Product Code: EHM FDA UDI
GMDN Term: Dental abrasive strip, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6010 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental abrasive strip, single-use

Epitex® by Gc America Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Gc America Inc.

Sources (1)

FDA UDI 114f319f-edb4-4dd8-8a24-6f826cad4186 36 fields · synced May 30, 2026