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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCARISOLV MINIMAL INVASIVE DENTAL CARIES REMOVAL SYSTEM
Classification Namesolution, removal, carries
ApplicantMEDITEAM AB
PMA NumberP000005
Supplement NumberS005
Date Received07/09/2002
Decision Date10/23/2002
Product Code
LMW
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the formulation of carisolv.
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