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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture, Plastic, Teeth
510(k) Number K984128
Device Name ENIGMA DENTURE TEETH
Applicant
Davis Schottlander & Davis, Ltd.
54 Riverview Ave.
Tonawanda,  NY  14150 -5260
Applicant Contact CLYDE E INGERSOLL
Correspondent
Davis Schottlander & Davis, Ltd.
54 Riverview Ave.
Tonawanda,  NY  14150 -5260
Correspondent Contact CLYDE E INGERSOLL
Regulation Number872.3590
Classification Product Code
ELM  
Date Received11/18/1998
Decision Date 02/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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