Overjet Calculus Assist

GUDID 00860005586325

Overjet, Inc.

Dental x-ray image interpretive software

• Primary Device ID: 00860005586325
• NIH Device Record Key: ca8c68d9-7743-4b7e-be45-029ebcb243c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Overjet Calculus Assist
• Version Model Number: v1
• Company DUNS: 116916753
• Company Name: Overjet, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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
GS1	00860005586325 [Primary]

FDA Product Code

• MYN: Analyzer, Medical Image

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: 2024-11-20
• Device Publish Date: 2024-11-12

Devices Manufactured by Overjet, Inc.

• 00860005586301 - Overjet Dental Assist: 2024-11-20
• 00860005586318 - Overjet Caries Assist: 2024-11-20
• 00860005586325 - Overjet Calculus Assist: 2024-11-20
• 00860005586325 - Overjet Calculus Assist: 2024-11-20
• 00860005586332 - Overjet Periapical Radiolucency Assist: 2024-11-20
• 00860005586349 - Overjet DI System: 2024-11-20
• 00860005586356 - Overjet Charting Assist: 2024-11-20
• 00860005586363 - Overjet Caries Assist-Pediatric: 2024-11-20
• 00860005586370 - Overjet Image Enhancement Assist: 2024-11-20