FDA 510(k), K212519, Overjet Caries Assist

510(K) Number: K212519
Device Name: Overjet Caries Assist
Manufacturer: Wardah Inam
Device Classification Name: Analyzer, Medical Image
Regulation Number: MYN
Classification Product Code: KXA
Date Received: 08/10/2021
Decision Date: 05/10/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

Total pages: 1,545
Fully redacted pages: 1,138
Content Pages: 407