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FDA 510(k) Application Details - K992102
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K992102
Device Name
Material, Tooth Shade, Resin
Applicant
LUMA LITE, INC,
477 MARINA PARKWAY #400
CHULA VISTA, CA 91910 US
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Contact
JOSEPH FOREHAND
Other 510(k) Applications for this Contact
Regulation Number
872.3690
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Classification Product Code
EBF
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More FDA Info for this Product Code
Date Received
06/21/1999
Decision Date
08/31/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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