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510(k) K965135

LIFECORE CONICAL ABUTMENT by Lifecore Biomedical, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1997
Date Received
December 23, 1996
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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  • K051614 — PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION (September 9, 2005)
  • K050506 — PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS (April 15, 2005)
  • K041324 — CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER (July 19, 2004)

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