SHQ — Dental Image Analyzer, In-Office Class II
FDA product code SHQ covers "Dental Image Analyzer, In-Office", a Class II medical device regulated under 21 CFR 872.1770. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SHQ
- Device Class
- Class II
- Regulation Number
- 872.1770
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260082 | 3Shape Trios | TRIOS Dx (R1) | Apr 10, 2026 |