LOGICON CARIES DETECTOR

Analyzer, Medical Image

FDA Premarket Approval P980025 S001

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 located at ga industries, rancho palos verdes, california.

DeviceLOGICON CARIES DETECTOR
Classification NameAnalyzer, Medical Image
Generic NameAnalyzer, Medical Image
ApplicantCARESTREAM DENTAL LLC
Date Received2006-05-25
Decision Date2007-01-12
PMAP980025
SupplementS001
Product CodeMYN
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CARESTREAM DENTAL LLC 1765 The Exchange atlanta, GA 30339

Supplemental Filings

Supplement NumberDateSupplement Type
P980025Original 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 IDPMASupp
60192156851628 P980025 000
60192155942754 P980025 004
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