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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K902744
Device Name DEGUFILL (TM) BOND
Applicant
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Correspondent
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/22/1990
Decision Date 08/15/1990
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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