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510(k) K072241

PRIMACONNEX CAD/CAM ABUTMENT SYSTEM by Lifecore Biomedical, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2007
Date Received
August 13, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by Lifecore Biomedical, Inc.

  • K073032 — PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS (November 16, 2007)
  • 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)
  • 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)
  • K032774 — RENOVA INTERNAL HEX IMPLANT SYSTEM (November 26, 2003)

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