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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K905387
Device Name DEGUDENT GS
Applicant
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Applicant Contact MEINICKE
Correspondent
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Correspondent Contact MEINICKE
Regulation Number872.3060
Classification Product Code
EJT  
Date Received11/30/1990
Decision Date 01/15/1991
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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