A-SOFT RELINER

Resin, Denture, Relining, Repairing, Rebasing

S & C POLYMER GMBH

The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for A-soft Reliner.

Pre-market Notification Details

Device IDK984483
510k NumberK984483
Device Name:A-SOFT RELINER
ClassificationResin, Denture, Relining, Repairing, Rebasing
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 CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-16
Decision Date1999-02-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EBIB738101 K984483 000

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