VENEER SYSTEM, MOSTIQUE LAMINATE

Agent, Tooth Bonding, Resin

CAULK CO., DIV. DENTSPLY

The following data is part of a premarket notification filed by Caulk Co., Div. Dentsply with the FDA for Veneer System, Mostique Laminate.

Pre-market Notification Details

Device IDK782080
510k NumberK782080
Device Name:VENEER SYSTEM, MOSTIQUE LAMINATE
ClassificationAgent, Tooth Bonding, Resin
Applicant CAULK CO., DIV. DENTSPLY 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-13
Decision Date1979-01-26

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