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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K973539
Device Name ROEKO CALCIUM HYDROXIDE POINTS
Applicant
Roeko USA, Inc.
100 Main St.
Suite 120
Concord,  MA  01742
Applicant Contact JAMES DELANEY
Correspondent
Roeko USA, Inc.
100 Main St.
Suite 120
Concord,  MA  01742
Correspondent Contact JAMES DELANEY
Regulation Number872.3250
Classification Product Code
EJK  
Date Received09/18/1997
Decision Date 10/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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