Logicon Caries Detection Software

Analyzer, Medical Image

FDA Premarket Approval P980025 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a manufacturing site in atlanta, ga, usa for logicon caries detection software.

• Device: Logicon Caries Detection Software
• Classification Name: Analyzer, Medical Image
• Generic Name: Analyzer, Medical Image
• Applicant: CARESTREAM DENTAL LLC
• Date Received: 2019-08-09
• Decision Date: 2019-09-05
• PMA: P980025
• Supplement: S004
• Product Code: MYN
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: CARESTREAM DENTAL LLC 1765 The Exchange atlanta, GA 30339

Supplemental Filings

Supplement Number	Date	Supplement Type
P980025		Original Filing
S004	2019-08-09	Normal 180 Day Track No User Fee
S003	2015-10-23	Normal 180 Day Track No User Fee
S002	2013-02-19	Normal 180 Day Track
S001	2006-05-25	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
60192156851628	P980025	000
60192155942754	P980025	004