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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
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