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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 K953344
Device Name DEGUBOND ULTRA
Applicant
Degussa AG
3900 S. Clinton Ave.
South Plainfield,  NJ  07080
Applicant Contact HOLGER MEINICKE
Correspondent
Degussa AG
3900 S. Clinton Ave.
South Plainfield,  NJ  07080
Correspondent Contact HOLGER MEINICKE
Regulation Number872.3060
Classification Product Code
EJT  
Date Received07/12/1995
Decision Date 08/25/1995
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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