PMA P980025S003

Device
LOGICON CARIES DETECTOR
Applicant
Carestream Dental, LLC
PMA number
P980025
Supplement
S003
Product code
MYN
Decision date
2015-12-10
Classification
Analyzer, Medical Image
Generic name
Analyzer, medical image
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT CARESTREAM DENTAL IN ATLANTA, GEORGIA.

Current openFDA PMA Record#

Device
LOGICON CARIES DETECTOR
Applicant
Carestream Dental, LLC
PMA number
P980025
Supplement
S003
Product code
MYN
Generic name
Analyzer, medical image
Decision date
2015-12-10
Decision code
APPR
Date received
2015-10-23
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT CARESTREAM DENTAL IN ATLANTA, GEORGIA.