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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 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.
 
DeviceCARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM
Classification Namesolution, removal, carries
Generic Namesolution, removal, carries
Applicant
MEDITEAM AB
goteborgsvagen 74,
savedalen S-433-433
PMA NumberP000005
Supplement NumberS001
Date Received10/10/2001
Decision Date02/05/2002
Product Code
LMW
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE CARISOLV POWER DRIVE.
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