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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 K924830
Device Name LUXATEMP AUTOMIX
Applicant
Dmg Chemisch Pharmazeutische Fabrik GmbH
Elbgaustrabe 148
2000 Hamburg 53
Germany,  GR
Applicant Contact GIESEN)
Correspondent
Dmg Chemisch Pharmazeutische Fabrik GmbH
Elbgaustrabe 148
2000 Hamburg 53
Germany,  GR
Correspondent Contact GIESEN)
Regulation Number872.3770
Classification Product Code
EBG  
Date Received09/25/1992
Decision Date 04/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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