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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K100100
Device Name DIO STEADY EXTERNAL IMPLANT SYSTEM
Applicant
Dio Corporation
3540 Wilshire Blvd. Suite
1104
Los Angeles,  CA  90010
Applicant Contact TIMOTHY LEE
Correspondent
Dio Corporation
3540 Wilshire Blvd. Suite
1104
Los Angeles,  CA  90010
Correspondent Contact TIMOTHY LEE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/12/2010
Decision Date 11/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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