ALPHA-DENT® Glass Ionomer Cement

FDA UDI

Class II (US FDA UDI)

by Dental Technologies, Inc.

Identity

Trade Name: ALPHA-DENT® Glass Ionomer Cement FDA UDI
Generic Name: Glass ionomer dental cement FDA UDI
Device Name: ALPHA-DENT® Glass Ionomer Cement is specially formulated for superior strength, resistance to dissolution, and oral retention. They are impervious to oral fluids, and thus permanent under oral conditions. The material is recommended for cementing crowns, inlays, orthodontic bands, temporary fillings, fixed bridges, or as a base under any filling material. Kit Contains: 16.5ml Liquid FDA UDI
Model / Reference: 307.0101.001 FDA UDI
Description: ALPHA-DENT® Glass Ionomer Cement is specially formulated for superior strength, resistance to dissolution, and oral retention. They are impervious to oral fluids, and thus permanent under oral conditions. The material is recommended for cementing crowns, inlays, orthodontic bands, temporary fillings, fixed bridges, or as a base under any filling material. Kit Contains: 16.5ml Liquid FDA UDI

Identifiers

Catalog Number: 307.0101.001 FDA UDI
Primary DI / UDI-DI: D73530701010010 FDA UDI
510(k) Number: K935436 FDA UDI
FDA Product Code: EMA FDA UDI
GMDN Term: Glass ionomer dental cement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3275 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

FDA UDI

Category: Glass ionomer dental cement

ALPHA-DENT® Glass Ionomer Cement by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glass ionomer dental cement.

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GC Fuji II LC® — Gc America Inc. · Class II

Cleared under the same submission

K935436 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	Class II	Pending data

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Manufacturer

Manufacturer: Dental Technologies, Inc.

Sources (1)

FDA UDI 3c9f0b54-e7e8-47a1-9ccd-b847492b45ac 37 fields · synced Jun 9, 2026