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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 K905220
Device Name MONOBOND S
Applicant
IVOCLAR NORTH AMERICA, INC.
175 PINEVIEW DR.
AMHERST,  NY  14228
Applicant Contact GARY SEVERANCE
Correspondent
IVOCLAR NORTH AMERICA, INC.
175 PINEVIEW DR.
AMHERST,  NY  14228
Correspondent Contact GARY SEVERANCE
Regulation Number872.3690
Classification Product Code
EBF  
Date Received11/20/1990
Decision Date 12/17/1990
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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