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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 K983414
Device Name EVERBOND
Applicant
ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Applicant Contact A. PETERMANN
Correspondent
ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Correspondent Contact A. PETERMANN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received09/28/1998
Decision Date 12/16/1998
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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