Device |
dental image analyzer |
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. |
Physical State |
May include hardware to capture the optical camera-based intraoral images and software to collect and analyze the images. |
Technical Method |
Software that collects and analyzes camera-based intraoral images to be used as a diagnostic aid and to monitor treatment progress. |
Target Area |
Oral Cavity/Mouth |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | SBC |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
872.1770
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|