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Coe-Rect™

FDA UDI

Class II (US FDA UDI)

by Gc America Inc.

Identity

Trade Name
COE-RECT™ FDA UDI
Generic Name
Denture reliner, hard FDA UDI
Device Name
COE-RECT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid, 1 x 14mL repair liquid & accessories) FDA UDI
Model / Reference
343001 FDA UDI
Description
COE-RECT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid, 1 x 14mL repair liquid & accessories) FDA UDI

Identifiers

Catalog Number
343001 FDA UDI
Primary DI / UDI-DI
10386040006903 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Denture reliner, hard 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Denture reliner, hard

A comprehensive device designed for denture relining, providing a durable and long-lasting surface for dental professionals to use in their daily practice. The COE-RECT Professional Package includes powder, liquid, repair liquid, and accessories, making it an essential tool for dentists and dental laboratories.

Similar devices

Also classified as Denture reliner, hard.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gc America Inc.

Sources (1)

  • FDA UDI 82506ff3-f35f-4c98-ac51-773a4e0aed05 36 fields · synced Jul 30, 2026