GC Fuji ORTHO™

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name: GC Fuji ORTHO™ FDA UDI
Generic Name: Glass ionomer dental cement FDA UDI
Device Name: GC Fuji ORTHO™ Intro Package, 1-2 Pack (1 x 40g powder, 2 x 6.8mL liquid & accessories) FDA UDI
Model / Reference: 439503 FDA UDI
Description: GC Fuji ORTHO™ Intro Package, 1-2 Pack (1 x 40g powder, 2 x 6.8mL liquid & accessories) FDA UDI

Identifiers

Catalog Number: 439503 FDA UDI
Primary DI / UDI-DI: 10386040009867 FDA UDI
510(k) Number: K961417 FDA UDI
FDA Product Code: DYH FDA UDI
GMDN Term: Glass ionomer dental cement FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 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 ORTHO™ by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K961417 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 df5a08d5-657b-47d5-82ea-29dde34e17b0 37 fields · synced May 30, 2026