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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K010940
Device Name SEALAPEX 4
Applicant
Sybron Dental Specialties, Inc.
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
Sybron Dental Specialties, Inc.
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3820
Classification Product Code
KIF  
Date Received03/29/2001
Decision Date 06/20/2001
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
Recalls CDRH Recalls
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