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SBCClass II

Dental Image Analyzer

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

SBC is the FDA product code for Dental Image Analyzer, a class II device type, regulated under 21 CFR 872.1770. FDA's definition for this code reads: "A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid to diagnosis of oral health conditions and/or to monitor treatment progress". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SBC
Device name
Dental Image Analyzer
FDA definition
A dental image analyzer is a prescription home use device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images. The analyses are provided to dental health care professionals as an aid to diagnosis of oral health conditions and/or to monitor treatment progress.
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 SBC

By decision year
1 clearance under product code SBC with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SBC by decision year
YearClearances
20241

Applicants with the most clearances

Product code SBC
Applicants holding the most 510(k) clearances under product code SBC
ApplicantClearances
Dental Monitoring SAS1

Companies listing this code with FDA

Companies whose registered establishments list this code