Check-Bite™

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name: CHECK-BITE™ FDA UDI
Generic Name: Dental impression spacer FDA UDI
Device Name: CHECK-BITE™ Occlusal Inserts, Package of 25 FDA UDI
Model / Reference: 262025 FDA UDI
Description: CHECK-BITE™ Occlusal Inserts, Package of 25 FDA UDI

Identifiers

Catalog Number: 262025 FDA UDI
Primary DI / UDI-DI: 10386040002677 FDA UDI
FDA Product Code: ELW FDA UDI
GMDN Term: Dental impression spacer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental impression spacer

Check-Bite™ by Gc America Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Gc America Inc.

Sources (1)

FDA UDI e6783fcc-9e5e-4c0b-b5fd-74de3c600b34 35 fields · synced Jun 8, 2026