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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K013179
Device Name LUXAGLAZE
Applicant
Dmg USA, Inc.
414 S. State St.
Dover,  DE  19901
Applicant Contact PAMELA PAPINEAU
Correspondent
Dmg USA, Inc.
414 S. State St.
Dover,  DE  19901
Correspondent Contact PAMELA PAPINEAU
Regulation Number872.3310
Classification Product Code
EBD  
Date Received09/24/2001
Decision Date 10/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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