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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
Model 2010CO THRU 2017CO, 2510CO THRU 2517CO, 3010CO THRU 3017CO, 2010XO THRU 2017XO, THRU 2517XO, 3010XO THRU 3017XO
Device Name LEW MDI O-BALL COLLARED IMPLANT,
Original Applicant
PARK DENTAL RESEARCH CORP.
2401 n commerce st ste b
ardmore,  OK  73401
Original Contact ronald bulard
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/11/2012
Decision Date 09/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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