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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K904135
Device Name FOUNDATION HYBRID COMPOSITE
Applicant
Nulite Systems Research
7/ 42 Leighton Pl.
Hornsby Nsw 2077
Australia,  AU
Applicant Contact CHRISTOPHER P DOUBE
Correspondent
Nulite Systems Research
7/ 42 Leighton Pl.
Hornsby Nsw 2077
Australia,  AU
Correspondent Contact CHRISTOPHER P DOUBE
Regulation Number872.3310
Classification Product Code
EBD  
Date Received09/06/1990
Decision Date 05/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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