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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K191619
Device Name TurboTemp EZ
Applicant
Zest Anchors, LLC
2875 Loker Ave. E
Carlsbad,  CA  92010
Applicant Contact Marysa E. Loustalot
Correspondent
Zest Anchors, LLC
2875 Loker Ave. E
Carlsbad,  CA  92010
Correspondent Contact Marysa E. Loustalot
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Code
POW  
Date Received06/18/2019
Decision Date 09/11/2019
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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