Diagnostic devices · 21 CFR 872 Subpart B
In-Office Dental Image Analyzer
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.
- Companies listing it
- 22 makers
- Brands and models
- 2
- 510(k) clearances
- 11 in five years
- FDA name
- Dental Image Analyzer, In-Office
510(k) clearances per year, 1976–2026
Companies that list SHQ
2 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| 3Shape Trios | Denmark | Maker | Trios Dx | 3 | 2026 |
| 3Shape A/S | Denmark | Maker | Trios Dx | 7 | 2020 |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 10 Apr 2026 | K260082 | TRIOS Dx (R1) | 3Shape Trios |
Official records: FDA product classification for SHQ · 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