ENIGMA HI-BASE DENTURE BASE MATERIAL

Resin, Denture, Relining, Repairing, Rebasing

DAVIS SCHOTTLANDER & DAVIS, LTD.

The following data is part of a premarket notification filed by Davis Schottlander & Davis, Ltd. with the FDA for Enigma Hi-base Denture Base Material.

Pre-market Notification Details

Device IDK993717
510k NumberK993717
Device Name:ENIGMA HI-BASE DENTURE BASE MATERIAL
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant DAVIS SCHOTTLANDER & DAVIS, LTD. 54 RIVERVIEW AVE. Tonawanda,  NY  14150 -5260
ContactClyde E Ingersoll
CorrespondentClyde E Ingersoll
DAVIS SCHOTTLANDER & DAVIS, LTD. 54 RIVERVIEW AVE. Tonawanda,  NY  14150 -5260
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-03
Decision Date1999-12-22

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