Dental Image Analyzer
A dental image analyzer is a prescription home-use software device that collects and analyzes patient-specific intraoral optical camera images, providing analyses to dental healthcare professionals as an aid in diagnosing oral health conditions and monitoring treatment progress. It is classified as FDA Class II (510(k) required) under regulation 872.1770 in the Dental specialty, with product code SBC. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SBC
- Device Class
- FDA class 2
- Regulation Number
- 872.1770
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN230035 | DentalMonitoring | May 17, 2024 | Unknown | Dental Monitoring Sas |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.