FDA.reportPublic FDA data

The George Gauge Kit

Primary DI
D7750560501
Brand
The George Gauge Kit
Company
Great Lakes Dental Technologies, Ltd.
Model
056-050
Device 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.
Published
2021-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7750560501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, reusableA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-828-7626info@greatlakesdentaltech.com

Regulatory Flags#

DUNS number
041854332
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

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D775IBN0Bonded HerbstIBN2026-05-07
D775IBNE0Bonded Herbst - RPEIBNE2026-05-07
D775IBNER0Bonded Herbst - RPE Removable LowerIBNER2026-05-07

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