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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plugger, root canal, endodontic
510(k) Number K031664
Device Name ELEMENTS OBTURATION UNIT
Applicant
SYBRON ENDO/ANALYTIC
15233 N.E. 90TH ST.
REDMOND,  WA  98052
Applicant Contact COLLEEN BOSWELL
Correspondent
SYBRON ENDO/ANALYTIC
15233 N.E. 90TH ST.
REDMOND,  WA  98052
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.4565
Classification Product Code
EKR  
Date Received05/29/2003
Decision Date 04/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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