SHQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dental Image Analyzer, In-Office
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.1770
- Medical specialty
- Dental
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| TRIOS Dx (R1) (K260082) | 3Shape TRIOS A/S | 2026-04-10 |
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