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510(k) K051614

PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS by Lifecore Biomedical, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2005
Date Received
June 17, 2005
Clearance Type
Abbreviated
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

Other clearances by Lifecore Biomedical, Inc.

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  • K072768 — RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS (October 23, 2007)
  • K072572 — PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS (October 5, 2007)
  • K062876 — PRIMACONNEX CERAMIC ABUTMENTS (November 1, 2006)
  • K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING F (May 22, 2006)
  • K053643 — STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 (January 23, 2006)
  • K050506 — PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS (April 15, 2005)
  • K041324 — CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER (July 19, 2004)
  • K032774 — RENOVA INTERNAL HEX IMPLANT SYSTEM (November 26, 2003)

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