GC Reline ™

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name: GC Reline ™ FDA UDI
Generic Name: Denture reliner, elastic, short-term FDA UDI
Device Name: GC Reline ™ Bonding Agent, 12g FDA UDI
Model / Reference: 346094 FDA UDI
Description: GC Reline ™ Bonding Agent, 12g FDA UDI

Identifiers

Catalog Number: 346094 FDA UDI
Primary DI / UDI-DI: D6583460941 FDA UDI
510(k) Number: K963144 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Denture reliner, elastic, short-term FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 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: Denture reliner, elastic, short-term

GC Reline ™ 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

K963144 also covers:

GC Reline ™ — Gc America Inc.

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 874bd962-997c-46ca-b079-d0d6cb35a46e 37 fields · synced May 30, 2026