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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K994012
Device Name TEMPOFIT, MODEL 02693
Applicant
Detax GmbH & Co. KG
7707 E. 201 Terr
Belton,  MO  64012
Applicant Contact BARRY HALE
Correspondent
Detax GmbH & Co. KG
7707 E. 201 Terr
Belton,  MO  64012
Correspondent Contact BARRY HALE
Regulation Number872.3770
Classification Product Code
EBG  
Date Received11/26/1999
Decision Date 02/16/2000
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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