S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL

Material, Impression

S & C POLYMER GMBH

The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for S & C Hydro Vinyl Polysiloxane Impression Material.

Pre-market Notification Details

Device IDK012767
510k NumberK012767
Device Name:S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
ClassificationMaterial, Impression
Applicant S & C POLYMER GMBH ROBERT-BOSCH-STRABE 5 Elmshorn,  DE D-25335
ContactChristian Bottcher
CorrespondentChristian Bottcher
S & C POLYMER GMBH ROBERT-BOSCH-STRABE 5 Elmshorn,  DE D-25335
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-17
Decision Date2001-11-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EHAR70837521 K012767 000
D6620708547782 K012767 000
EHAR70837011 K012767 000
EHAR70837021 K012767 000
EHAR70837111 K012767 000
EHAR70837121 K012767 000
EHAR70837211 K012767 000
EHAR70837221 K012767 000
EHAR70837311 K012767 000
EHAR70837321 K012767 000
EHAR70837331 K012767 000
EHAR70837401 K012767 000
EHAR70837411 K012767 000
EHAR70837421 K012767 000
EHAR70837511 K012767 000
D6620708547602 K012767 000

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