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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sealant, pit and fissure, and conditioner
510(k) Number K932078
Device Name HELIOSEAL F
Applicant
IVOCLAR NORTH AMERICA, INC.
175 PINEVIEW DR.
AMHERST,  NY  14228
Applicant Contact LLOYD ZIEMENDORF
Correspondent
IVOCLAR NORTH AMERICA, INC.
175 PINEVIEW DR.
AMHERST,  NY  14228
Correspondent Contact LLOYD ZIEMENDORF
Regulation Number872.3765
Classification Product Code
EBC  
Date Received04/29/1993
Decision Date 09/15/1993
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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