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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 K992048
Device Name MODIFICATION OF PROMPT L-POP
Applicant
Espe Dental AG
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Applicant Contact ANDREAS PETERMANN
Correspondent
Espe Dental AG
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Correspondent Contact ANDREAS PETERMANN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/17/1999
Decision Date 08/16/1999
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
Recalls CDRH Recalls
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