XP Composite

Material, Tooth Shade, Resin

S&C Polymer Silicon- Und Composite Spezialitaeten GmbH

The following data is part of a premarket notification filed by S&c Polymer Silicon- Und Composite Spezialitaeten Gmbh with the FDA for Xp Composite.

Pre-market Notification Details

Device IDK182780
510k NumberK182780
Device Name:XP Composite
ClassificationMaterial, Tooth Shade, Resin
Applicant S&C Polymer Silicon- Und Composite Spezialitaeten GmbH Robert-Bosch-Str. 2 Elmshorn,  DE 25335
ContactChristian Boettcher
CorrespondentChristian Boettcher
S&C Polymer Silicon- Und Composite Spezialitaeten GmbH Robert-Bosch-Str. 2 Elmshorn,  DE 25335
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-01
Decision Date2019-07-03

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