SBC — Dental Image Analyzer Class II
Classification Details
- Product Code
- SBC
- Device Class
- Class II
- Regulation Number
- 872.1770
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230035 | dental monitoring | DentalMonitoring | May 17, 2024 |