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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 K991808
Device Name OPTIBOND SOLO PLUS 2
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3200
Classification Product Code
KLE  
Date Received05/27/1999
Decision Date 07/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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