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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM
Classification Namesolution, removal, carries
ApplicantMEDITEAM AB
PMA NumberP000005
Date Received01/10/2000
Decision Date06/27/2001
Product Code
LMW
Docket Number 01M-0337
Notice Date 08/13/2001
Advisory Committee Dental
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S005 
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