ENIGMA DENTURE TEETH

Denture, Plastic, Teeth

DAVIS SCHOTTLANDER & DAVIS, LTD.

The following data is part of a premarket notification filed by Davis Schottlander & Davis, Ltd. with the FDA for Enigma Denture Teeth.

Pre-market Notification Details

Device IDK984128
510k NumberK984128
Device Name:ENIGMA DENTURE TEETH
ClassificationDenture, Plastic, Teeth
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 CodeELM  
CFR Regulation Number872.3590 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-18
Decision Date1999-02-09

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