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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 K921701
Device Name DURAFILL BOND
Applicant
Heraeus Kulzer, Inc.
10005 Muirlands Blvd.
Irvine,  CA  92718
Applicant Contact SHARON PARKER
Correspondent
Heraeus Kulzer, Inc.
10005 Muirlands Blvd.
Irvine,  CA  92718
Correspondent Contact SHARON PARKER
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/08/1992
Decision Date 06/09/1992
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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