HARD 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 Hard Reliner.

Pre-market Notification Details

Device IDK011277
510k NumberK011277
Device Name:HARD RELINER
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn,  DE D-25335
ContactJurgen Engelbrecht
CorrespondentJurgen Engelbrecht
S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn,  DE D-25335
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-26
Decision Date2001-06-26

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