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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K062219
Device Name PRODRIVE SYSTEMS REPLACEMENT TURBINE
Applicant
Prodrive Systems, Inc.
6062 Armstrong Rd.
Spencerville, Ontario,  CA K0E 1X0
Applicant Contact TIM NASON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.4200
Classification Product Code
EFB  
Date Received08/02/2006
Decision Date 08/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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