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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K983574
Device Name STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
Applicant
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact WILLIAM GUSCOTT
Correspondent
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact WILLIAM GUSCOTT
Regulation Number872.4200
Classification Product Code
EGS  
Date Received10/13/1998
Decision Date 01/08/1999
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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