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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K934783
Device Name KAVO INTRASEPT 905
Applicant
Kavo America
340 E. Main St.
Lake Zurich,  IL  60047
Applicant Contact EDWARD STOGENSON
Correspondent
Kavo America
340 E. Main St.
Lake Zurich,  IL  60047
Correspondent Contact EDWARD STOGENSON
Regulation Number872.6640
Classification Product Code
EIA  
Date Received10/06/1993
Decision Date 05/16/1994
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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