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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, tooth shade, resin
510(k) Number K001899
Device Name IMPROVED TRY-IN GEL
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 Number872.3690
Classification Product Code
EBF  
Date Received06/22/2000
Decision Date 08/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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