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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental
510(k) Number K090055
Device Name LOW & HIGH SPEED KIT
Applicant
Dpm USA Corp.
1460 NW 107 Ave. Suite G
Miami,  FL  33172
Applicant Contact GEORGE ECHEVERRI
Correspondent
Dpm USA Corp.
1460 NW 107 Ave. Suite G
Miami,  FL  33172
Correspondent Contact GEORGE ECHEVERRI
Regulation Number872.4200
Classification Product Code
EFA  
Date Received01/08/2009
Decision Date 10/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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