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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 K855211
Device Name PANAVIA EX, A DENTAL ADHESIVE
Applicant
Kuraray Co.
875 Ave. Of The Americas
New York,  NY  10001
Applicant Contact PAUL ROBERTS
Correspondent
Kuraray Co.
875 Ave. Of The Americas
New York,  NY  10001
Correspondent Contact PAUL ROBERTS
Regulation Number872.3275
Classification Product Code
EMA  
Date Received12/30/1985
Decision Date 03/13/1986
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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