Overjet CBCT Assist

GUDID 00860005586394

Overjet, Inc.

Panoramic/tomographic dental x-ray system application software

• Primary Device ID: 00860005586394
• NIH Device Record Key: 66d6e3b1-d4b2-4085-82c5-a57165903c20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Overjet CBCT 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	00860005586394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251514

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2025-12-22
• Device Publish Date: 2025-12-12

Devices Manufactured by Overjet, Inc.

• 00860005586394 - Overjet CBCT Assist: 2025-12-22
• 00860005586394 - Overjet CBCT Assist: 2025-12-22
• 00860005586301 - Overjet Dental Assist: 2024-11-20
• 00860005586318 - Overjet Caries 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