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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K993897
Device Name CERGOGOLD
Applicant
Degussa - Ney Dental, Inc.
1065 SW 30th Ave.
Deerfield Beach,  FL  33442 -8193
Applicant Contact ANDREW J PIETROBONO
Correspondent
Degussa - Ney Dental, Inc.
1065 SW 30th Ave.
Deerfield Beach,  FL  33442 -8193
Correspondent Contact ANDREW J PIETROBONO
Regulation Number872.6660
Classification Product Code
EIH  
Date Received11/16/1999
Decision Date 01/10/2000
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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