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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 K954708
Device Name SILANE PRIMER
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1332 SOUTH LONE HILL AVE.
GLENDORA,  CA  91740
Applicant Contact JEFFERY A ANDERSON
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1332 SOUTH LONE HILL AVE.
GLENDORA,  CA  91740
Correspondent Contact JEFFERY A ANDERSON
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/12/1995
Decision Date 10/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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