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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 K973876
Device Name PROPHYFLEX 2, MODEL 2012
Applicant
Kavo America
One Prudential Plz.,
130 E. Randolph
Chicago,  IL  60601
Applicant Contact GREGORY W BOWMAN
Correspondent
Kavo America
One Prudential Plz.,
130 E. Randolph
Chicago,  IL  60601
Correspondent Contact GREGORY W BOWMAN
Regulation Number872.4200
Classification Product Code
EFB  
Date Received10/10/1997
Decision Date 12/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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