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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 K120218
Device Name TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)
Applicant
Palm Beach Dental Supply D/B/A Tek USA
2700 NE 24th St.
Pompano Beach,  FL  33069
Applicant Contact MICHAEL CALHOUN
Correspondent
Palm Beach Dental Supply D/B/A Tek USA
2700 NE 24th St.
Pompano Beach,  FL  33069
Correspondent Contact MICHAEL CALHOUN
Regulation Number872.4200
Classification Product Code
EFB  
Date Received01/25/2012
Decision Date 06/29/2012
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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