GC Fuji LINING™

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name: GC Fuji LINING™ FDA UDI
Generic Name: Glass ionomer dental cement FDA UDI
Device Name: GC Fuji LINING™ Intro Package, 1-1 Pack (1 x 10 g powder, 1 x 6.8 mL liquid & accessories) FDA UDI
Model / Reference: 000021 FDA UDI
Description: GC Fuji LINING™ Intro Package, 1-1 Pack (1 x 10 g powder, 1 x 6.8 mL liquid & accessories) FDA UDI

Identifiers

Catalog Number: 000021 FDA UDI
Primary DI / UDI-DI: 14548161282833 FDA UDI
510(k) Number: K901999 FDA UDI
FDA Product Code: EJK FDA UDI
GMDN Term: Glass ionomer dental cement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3250 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

GC Fuji LINING™ by Gc America 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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Prontolute Glass Ionomer Luting Cement 30g — ADVANCED HEALTHCARE LTD. · Class IIa

Cleared under the same submission

K901999 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: Gc America Inc.

Sources (1)

FDA UDI 6f46a582-d787-48da-8d4e-daa228d541bd 37 fields · synced Jun 1, 2026