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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 -2595
Applicant Contact SHARON PARKER
Correspondent
HERAEUS KULZER, INC.
10005 MUIRLANDS BLVD.
IRVINE,  CA  92718 -2595
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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