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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K971622
Device Name MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM
Applicant
Mpl Technologies, Inc.
9400 King St.
Franklin Park,  IL  60131
Applicant Contact DANIEL J OSTERBY
Correspondent
Mpl Technologies, Inc.
9400 King St.
Franklin Park,  IL  60131
Correspondent Contact DANIEL J OSTERBY
Regulation Number872.3820
Classification Product Code
KIF  
Date Received05/02/1997
Decision Date 06/20/1997
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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