LC MICROHYBRID

Material, Tooth Shade, Resin

S & C POLYMER GMBH

The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Lc Microhybrid.

Pre-market Notification Details

Device IDK984484
510k NumberK984484
Device Name:LC MICROHYBRID
ClassificationMaterial, Tooth Shade, Resin
Applicant S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn,  DE
ContactJurgen Engelbrecht
CorrespondentJurgen Engelbrecht
S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn,  DE
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-16
Decision Date1999-01-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00850194007541 K984484 000
EBIB751041 K984484 000
00818207020109 K984484 000

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