DeviceClearance

Product code SBC— Dental

DentalMonitoring

Classification name
Dental Image Analyzer
Device class
Class 2
Regulation
21 CFR 872.1770
Advisory panel
Dental
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SBC under 21 CFR 872.1770, via openFDA

Market context for product code SBC

FDA has cleared 1 device under product code SBC, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SBC

Recent clearances under product code SBC

Data sourced from openFDA. This site is unofficial and independent of the FDA.