The George Gauge Kit

FDA UDI

Class I (US FDA UDI)

by Great Lakes Dental Technologies

Identity

Trade Name: The George Gauge Kit FDA UDI
Generic Name: Dental impression tray, reusable FDA UDI
Device Name: Ideal for mandibular repositioning, the George Gauge allows the clinician to capture the protrusive bite registration and vertical opening without relying on the patient to achieve proper positioning. Eliminates guesswork. Extremely accurate and easy to use. FDA UDI
Model / Reference: 056-050 FDA UDI
Description: Ideal for mandibular repositioning, the George Gauge allows the clinician to capture the protrusive bite registration and vertical opening without relying on the patient to achieve proper positioning. Eliminates guesswork. Extremely accurate and easy to use. FDA UDI

Identifiers

Primary DI / UDI-DI: D7750560501 FDA UDI
FDA Product Code: EHY FDA UDI
GMDN Term: Dental impression tray, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6880 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental impression tray, reusable

The George Gauge Kit by Great Lakes Dental Technologies — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Great Lakes Dental Technologies

Sources (1)

FDA UDI 5cd607e4-f92a-4fca-887d-e4dd57735ec3 34 fields · synced May 30, 2026