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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K010415
Device Name ISODAN
Applicant
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036 -5339
Applicant Contact PETER S REICHERZ
Correspondent
Specialites Septodont
1050 Connecticut Ave., NW
Washington,  DC  20036 -5339
Correspondent Contact PETER S REICHERZ
Regulation Number872.3200
Classification Product Code
KLE  
Date Received02/12/2001
Decision Date 07/23/2001
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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