Restore, Stage-1, Renova Primasolo and Primaconnex Dental Implants

• • Terminated Z-1179-2018 FDA Class III ·initiated 16 Oct 2017

  A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.

• • Terminated Z-0727-2018 FDA Class II ·initiated 25 Aug 2017

  The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.

510(k) Number

K072768 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Hapset Hydroxylapatite Bone Graft Plaster

  Class II

  FDA 510(k) K910432 Active Cleared 1 May 1991

• Stage- 1 Temporary/Healing Cap, Model 42021-42026

  Class II

  FDA 510(k) K053643 Active Cleared 23 Jan 2006

• Capset Calcium Sulfate Bone Graft Plaster

  Class II

  FDA 510(k) K943186 Active Cleared 10 Apr 1995

• Restore Ha Dental Implant System

  Class II

  FDA 510(k) K954865 Active Cleared 11 Jan 1996

• Primaconnex Sd Esthetic Contour Zi Abutments

  Class II

  FDA 510(k) K073032 Active Cleared 16 Nov 2007

• Restore Self Tapping Dental Implant Syst (5, 5.5, 6mm)

  Class II

  FDA 510(k) K944068 Active Cleared 2 Feb 1995

See all devices from Lifecore Biomedical, Inc. →