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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM
Generic NameSOLUTION, REMOVAL, CARRIES
ApplicantRLS GLOBAL AB
Neongatan 5
Molndal S-431-431-
PMA NumberP000005
Date Received01/10/2000
Decision Date06/27/2001
Withdrawal Date 06/09/2022
Product Code LMW 
Docket Number 01M-0337
Notice Date 08/13/2001
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CARISOLV(TM) NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM. THE DEVICE IS INTENDED FOR THE CHEMO-MECHANICAL SOFTENING AND REMOVAL OF DENTIN CARIES WHEN USED IN CONJUNCTION WITH A DENTAL HANDPIECE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S005 
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