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Dental Image Analyzer, In-Office

FDA product code SHQ · 1 cleared devices

Class 2 Dental
Regulation
21 CFR 872.1770
Review panel
DE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-04-10 – 2026-04-10

A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to diagnosis of oral health conditions.

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