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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K972890
Device Name ENLIGHT (TENTATIVE NAME)
Applicant
Sybron Dental Specialties, Inc.
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact WILLIAM R PIKE
Correspondent
Sybron Dental Specialties, Inc.
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact WILLIAM R PIKE
Regulation Number872.3750
Classification Product Code
DYH  
Date Received08/05/1997
Decision Date 09/16/1997
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
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