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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 K905155
Device Name HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES
Applicant
Star Dental Mfg. Co.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact GARY FOSS
Correspondent
Star Dental Mfg. Co.
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact GARY FOSS
Regulation Number872.4200
Classification Product Code
EFB  
Date Received11/15/1990
Decision Date 02/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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