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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K080246
Device Name COMPOSITE ALIGNER BUTTON
Applicant
Dentsply Interntional
221 W. Philadelphia St. Suite 60
Susquehanna Commerce Crt. W.
York,  PA  17405
Applicant Contact HELEN LEWIS
Correspondent
Dentsply Interntional
221 W. Philadelphia St. Suite 60
Susquehanna Commerce Crt. W.
York,  PA  17405
Correspondent Contact HELEN LEWIS
Regulation Number872.5470
Classification Product Code
NXC  
Date Received01/31/2008
Decision Date 04/11/2008
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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