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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 K771325
Device Name NIMETIC ETCHING GEL
Applicant
ESPE GMBH (US)
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ESPE GMBH (US)
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/18/1977
Decision Date 08/02/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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