Devices · CARESTREAM DENTAL LLC

LOGICON CARIES DETECTOR

CARESTREAM DENTAL LLC is listed for LOGICON CARIES DETECTOR (P980025). The FDA list gives September 2, 1998 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the PMA pathway. openFDA describes product code MYN as “Analyzer, Medical Image”: For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980025

Official FDA database record

Date of final decision

September 2, 1998

Company on the FDA list

CARESTREAM DENTAL LLC

Lead panel

Radiology

Primary product code

MYN

openFDA device name for the code

Analyzer, Medical Image

Device class

2

Regulation number

892.2070

openFDA decision description

Not returned

openFDA decision code

Not returned

Statement or summary label

Not returned