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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 K972910
Device Name PORS ON LITE
Applicant
Degussa Corp.
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Applicant Contact HOLGER MEINICKE
Correspondent
Degussa Corp.
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Correspondent Contact HOLGER MEINICKE
Regulation Number872.3060
Classification Product Code
EJT  
Date Received08/07/1997
Decision Date 10/14/1997
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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