SHQ · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.1770
Classification
FDA Product Code
SHQ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.1770
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.