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SHQClass II

Dental Image Analyzer, In-Office

21 CFR 872.1770 / Dental
FDA source (opens on fda.gov)

SHQ is the FDA product code for Dental Image Analyzer, In-Office, a class II device type, regulated under 21 CFR 872.1770. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SHQ
Device name
Dental Image Analyzer, In-Office
FDA 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.
Regulation
21 CFR 872.1770
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SHQ

By decision year
1 clearance under product code SHQ with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SHQ by decision year
YearClearances
20261

Applicants with the most clearances

Product code SHQ
Applicants holding the most 510(k) clearances under product code SHQ
ApplicantClearances
3SHAPE Trios a/S1

Companies listing this code with FDA

Companies whose registered establishments list this code