LC GLOSSFILL XR

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 Lc Glossfill Xr.

Pre-market Notification Details

Device IDK182778
510k NumberK182778
Device Name:LC GLOSSFILL XR
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 Date2019-04-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D6620712583910 K182778 000
D6620712583830 K182778 000
D6620712583750 K182778 000
D6620712583590 K182778 000

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