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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Teeth, Porcelain
510(k) Number K931808
Device Name DUCERAGOLD, DUCERATIN
Applicant
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Applicant Contact HOLGER MEINICKE
Correspondent
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Correspondent Contact HOLGER MEINICKE
Regulation Number872.3920
Classification Product Code
ELL  
Date Received04/12/1993
Decision Date 11/03/1993
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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