SHQ
- Product code
- SHQ
- Device name
- Dental Image Analyzer, In-Office
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.1770
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260082 | 2026-04-10 | 3Shape TRIOS A/S | TRIOS Dx (R1) |
Official FDA classification page: SHQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).