PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)

Resin, Denture, Relining, Repairing, Rebasing

KOHLER MEDIZINTECHNIK GMBH & CO. KG

The following data is part of a premarket notification filed by Kohler Medizintechnik Gmbh & Co. Kg with the FDA for Permafix Chairside Soft Denture Relining (7010) (7011-13) (7014-15).

Pre-market Notification Details

Device IDK980616
510k NumberK980616
Device Name:PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant KOHLER MEDIZINTECHNIK GMBH & CO. KG DANNINGEN 9 Neuhausen,  DE D-78579
ContactDagmar S Maser
CorrespondentDagmar S Maser
KOHLER MEDIZINTECHNIK GMBH & CO. KG DANNINGEN 9 Neuhausen,  DE D-78579
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-18
Decision Date1998-04-30

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