Accuguard

GUDID D775JAGFP0

Accuguard Flat Plane

Great Lakes Dental Technologies, Ltd.

Removable dental occlusal splint, custom-made

• Primary Device ID: D775JAGFP0
• NIH Device Record Key: 53853b64-6367-40d6-a449-6abe3cb04020
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accuguard
• Version Model Number: JAGFP
• Company DUNS: 041854332
• Company Name: Great Lakes Dental Technologies, Ltd.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D775JAGFP0 [Primary]

FDA Product Code

• KMY: Positioner, Tooth, Preformed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-26
• Device Publish Date: 2026-01-16

Devices Manufactured by Great Lakes Dental Technologies, Ltd.

• D775JAGFP0 - Accuguard: 2026-01-26Accuguard Flat Plane
• D775JAGFP0 - Accuguard: 2026-01-26 Accuguard Flat Plane
• D7752651001 - Titanium Molybdenum Wire: 2022-03-31 Titanium Molybdenum Wire, 14 inch length, Used in Retainers
• D7752651011 - Titanium Molybdenum Wire: 2022-03-31 Titanium Molybdenum Wire - 14 inches in length
• D7752651021 - Titanium Molybdenum Wire: 2022-03-31 Titanium Molybdenum Wire - 14 inches in Length
• D7750560501 - The George Gauge Kit: 2021-02-16 Ideal for mandibular repositioning, the George Gauge allows the clinician to capture the protrusive bite registration and vertic