FDA 510(k), K210187, Overjet Dental Assist

510(K) Number: K210187
Device Name: Overjet Dental Assist
Manufacturer: Adam Heroux
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 01/25/2021
Decision Date: 05/19/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

• Total Pages: 675
• Fully Redacted Pages: 316
• Content Pages: 359 (Total pages minus fully redacted pages)