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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 K121707
Device Name LEW MDI O-BALL COLLARED IMPLANT,
Applicant
Park Dental Research Corp.
2401 N Commerce St. Suite B
Ardmore,  OK  73401
Applicant Contact RONALD BULARD
Correspondent
Park Dental Research Corp.
2401 N Commerce St. Suite B
Ardmore,  OK  73401
Correspondent Contact RONALD BULARD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/11/2012
Decision Date 09/24/2012
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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