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510(k) K121707

LEW MDI O-BALL COLLARED IMPLANT, by Park Dental Research Corp. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2012
Date Received
June 11, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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