SwissPlant Dental Implant System

• • Terminated Z-1126-2020 FDA Class II ·initiated 9 Jan 2019

  Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.

• • Terminated Z-1168-2018 FDA Class II ·initiated 19 Jan 2018

  The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).

• • Terminated Z-0396-2016 FDA Class II ·initiated 28 Oct 2015

  Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.

510(k) Number

K081396 ↗

FDA Product Code

NHA

Device Class

Class II

Regulation

21 CFR Part 872.3630

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Spectra System Dental Implants 2008

  Class II

  FDA 510(k) K090234 Active Cleared 15 May 2009

• Screwplus Dental Implants (Ha)

  Class II

  FDA 510(k) K073049 Active Cleared 13 Dec 2007

• Spectra-System Abutments 2008

  Class II

  FDA 510(k) K081101 Active Cleared 14 Jan 2009

• Legacy Dental Implants

  Class II

  FDA 510(k) K073033 Active Cleared 10 Dec 2007

• Spectra System

  Class II

  FDA 510(k) K061319 Active Cleared 29 Sep 2006

• Screwindirect Dental Implants

  Class II

  FDA 510(k) K080633 Active Cleared 15 Jul 2008

See all devices from Implant Direct, LLC →

• What is the SwissPlant Dental Implant System used for?

  The SwissPlant Dental Implant System is designed for osseointegrated replacement of missing teeth in patients with edentulous (toothless) sites. It is intended for use in oral and maxillofacial surgery to restore either single-tooth or multi-tooth prosthetics, providing a stable foundation for dental crowns or bridges.

• How is the SwissPlant Dental Implant System supplied and what are its sterility and reuse details?

  The SwissPlant Dental Implant System is supplied as a sterile, single-use implant. This ensures optimal safety and reduces the risk of cross-contamination during surgical procedures. Each implant is intended for one-time use only, adhering to standard sterile medical device protocols.

• What diameters and variants are available for the SwissPlant Dental Implant System?

  The SwissPlant Dental Implant System is available in various diameters, including the 6.5mm Wide Neck (WN) variant. These variations allow for customized placement based on patient anatomy and clinical requirements, ensuring a tailored fit for different edentulous sites.

• What abutment systems is the SwissPlant Dental Implant System compatible with?

  The SwissPlant Dental Implant System features an internal octagonal Morse taper connection, which provides stability and compatibility with specific abutment systems, including ITI-Straumann and SybronPRO XRT. However, regulatory approval for these combinations is tied to the FDA 510(k) clearance for the SwissPlant system as a whole.

• How should the SwissPlant Dental Implant System be stored and handled?

  The SwissPlant Dental Implant System must be stored and handled according to sterile medical device protocols to maintain its integrity and sterility. Proper storage ensures the implants remain uncontaminated and ready for surgical use, adhering to best practices for single-use medical devices.