SBC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dental Image Analyzer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.1770
- Medical specialty
- Dental
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| DentalMonitoring (DEN230035) | Dental Monitoring Sas | 2024-05-17 |
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