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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K003714
Device Name OSSTELL RESONANCE FREQUENCY ANALYZER
Applicant
Integration Diagnostics, Ltd.
6470 Riverview Ter.
Findley,  MN  55432
Applicant Contact CONSTANCE BUNDY
Correspondent
Integration Diagnostics, Ltd.
6470 Riverview Ter.
Findley,  MN  55432
Correspondent Contact CONSTANCE BUNDY
Regulation Number872.4200
Classification Product Code
EKX  
Date Received12/01/2000
Decision Date 08/09/2001
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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