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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K152110
Device Name e-1 etchants
Applicant
E Dental Products
216 W. Watauga Ave.
Johnson City,  TN  37604
Applicant Contact JEFF BANYAS
Correspondent
E Dental Products
216 W. Watauga Ave.
Johnson City,  TN  37604
Correspondent Contact JEFF BANYAS
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/29/2015
Decision Date 11/20/2015
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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