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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K021126
Device Name EVERSTICK ORTHO
Applicant
Stick Tech , Ltd.
80 Pkwy. W.
Mount Vernon,  NY  10552
Applicant Contact WILLIAM TROETEL
Correspondent
Stick Tech , Ltd.
80 Pkwy. W.
Mount Vernon,  NY  10552
Correspondent Contact WILLIAM TROETEL
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Code
DYT  
Date Received04/08/2002
Decision Date 05/13/2002
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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