Last synced on 19 July 2024 at 11:05 pm

Dental Image Analyzer

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.1770
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code SBC is linked to regulation 21CFR872.1770, which does not seem to exist yet. It may be pending at the moment.

Dental Image Analyzer

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.1770
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code SBC is linked to regulation 21CFR872.1770, which does not seem to exist yet. It may be pending at the moment.