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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K910719
Device Name SILICOATER MD
Applicant
Kulzer, Inc.
10005 Muirlands Blvd.
Unit G.
Irvine,  CA  92718
Applicant Contact SHARON PARKER
Correspondent
Kulzer, Inc.
10005 Muirlands Blvd.
Unit G.
Irvine,  CA  92718
Correspondent Contact SHARON PARKER
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/20/1991
Decision Date 04/29/1991
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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