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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 Ste B
Ardmore,  OK  73401
Applicant Contact RONALD BULARD
Correspondent
PARK DENTAL RESEARCH CORP.
2401 N Commerce St Ste 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
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