Product code SHQ

Device name

Dental Image Analyzer, In-Office

Medical specialty

Dental

Device class

2

Regulation number

872.1770

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset