Procera Preparable Abutment System

• 2 recalls, same reason

  • Terminated Z-1853-2020 FDA Class II ·initiated 9 Aug 2019
  • Terminated Z-1852-2020 FDA Class II ·initiated 9 Aug 2019

  Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.

510(k) Number

K974150 ↗

FDA Product Code

NHA

Device Class

Class II

Regulation

21 CFR Part 872.3630

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Replace One Piece Implant, Ha, Replace One Piece Implant, Tiunite

  Class II

  FDA 510(k) K023952 Active Cleared 16 Jan 2003

• Nobel Perfect Implant System

  Class II

  FDA 510(k) K030257 Active Cleared 10 Feb 2003

• Replace Ha Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162

  Class II

  FDA 510(k) K020646 Active Cleared 29 May 2002

• Inplant Orthodontic Anchor System

  Class II

  FDA 510(k) K000643 Active Cleared 7 Sep 2000

• Branemark System(R) Ebon(Tm) Fixture

  Class II

  FDA 510(k) K974828 Active Cleared 24 Mar 1998

• Branemark System Zygomaticus Fixture System

  Class II

  FDA 510(k) K970499 Active Cleared 16 Oct 1997

See all devices from Nobel Biocare Uas, Inc. →

• What is the Procera Preparable Abutment System used for in dental procedures?

  The Procera Preparable Abutment System is designed as a screw-retained component for endosseous dental implants. It acts as a foundation to which prosthetic restorations—such as artificial teeth—are attached using dental cement, restoring chewing function and stability. It is specifically intended for use in dental implant procedures where a customizable abutment is required.

• Is the Procera Preparable Abutment System meant for reuse in multiple patients?

  No, the Procera Preparable Abutment System is explicitly supplied for single-use only in dental procedures. This aligns with standard dental implant protocols to ensure patient safety and sterility, as reuse is not authorized or recommended for this system.

• How should the Procera Preparable Abutment System be stored according to manufacturer guidelines?

  Storage follows standard dental implant protocols, which typically include keeping the system in a clean, dry environment protected from contamination. Since it is intended for single-use, it should be stored in its original packaging until ready for immediate use, adhering to regulatory requirements for dental devices to maintain sterility and integrity.

• What regulatory pathway was followed for FDA clearance of the Procera Preparable Abutment System?

  The Procera Preparable Abutment System received FDA clearance through a 510(k) submission (K974150), classified under the Dental (DE) advisory committee with a decision of Substantially Equivalent (SESE). The clearance was granted under a Traditional 510(k) review, meaning it was determined to be comparable to a legally marketed predicate device for dental applications.