Diagnostic devices · 21 CFR 872 Subpart B
Dental Image Analyzer
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.
- Companies listing it
- 11 makers
- Brands and models
- 1
- 510(k) clearances
- 11 in five years
- FDA name
- Dental Image Analyzer
510(k) clearances per year, 1976–2026
Companies that list SBC
1 company currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dental Monitoring | France | Maker | DentalMonitoring | 1 | 2024 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 17 May 2024 | DEN230035 | DentalMonitoring | Dental Monitoring |
Official records: FDA product classification for SBC · 21 CFR 872.1770.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026