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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Pulp Canal, Endodontic
510(k) Number K864976
Device Name SOLUSET CALCIUM DEMINERALIZING SOLUTION
Applicant
Endo Technic Corp.
One Apple Hill Suite 316
Natick,  MA  01760
Applicant Contact STEWART LUSTGARTEN
Correspondent
Endo Technic Corp.
One Apple Hill Suite 316
Natick,  MA  01760
Correspondent Contact STEWART LUSTGARTEN
Regulation Number872.4565
Classification Product Code
EKS  
Date Received12/19/1986
Decision Date 02/27/1987
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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