Surgical Vitex

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K862926 ↗

FDA Product Code

ELE

Device Class

Class II

Regulation

21 CFR Part 872.3645

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Naturelle II & Lite Ii-N72-N74-L

  Class II

  FDA 510(k) K833774 Active Cleared 24 Jan 1984

• Rexillium N. B. F.

  Class II

  FDA 510(k) K862822 Active Cleared 2 Sep 1986

• Rexillium III

  Class II

  FDA 510(k) K833143 Active Cleared 8 Dec 1983

• Luxor Porcelain

  Class II

  FDA 510(k) K820057 Active Cleared 2 Mar 1982

• Rx Universal

  Class II

  FDA 510(k) K822950 Active Cleared 22 Oct 1982

• Rx Elan

  Class II

  FDA 510(k) K840561 Active Cleared 1 May 1984

See all devices from Jeneric Ind. →

• What types of dental procedures is the Surgical Vitex intended to support or augment?

  The Surgical Vitex is designed for dental applications where subperiosteal placement is required to support or augment dental structures. This includes procedures where the implant is positioned beneath the periosteum to provide structural reinforcement or enhancement, such as in cases of bone loss or reconstruction.

• Is the Surgical Vitex available in reusable or single-use versions, and how does that relate to its mesh size?

  The Surgical Vitex is supplied as either reusable or single-use, depending on its mesh size. Implants with a mesh size of 20-40 are typically reusable, while those with a mesh size of 40-60 are intended for single-use. This distinction is likely due to material durability and sterility considerations.

• What storage and handling requirements apply to the Surgical Vitex, and why?

  The Surgical Vitex must be stored and handled under sterile or aseptic protocols, as it is a surgical implant. This is a standard requirement for all implants to prevent contamination and ensure patient safety during dental procedures.

• What is the regulatory pathway for the Surgical Vitex, and how was its classification determined?

  The Surgical Vitex follows the FDA’s 510(k) clearance pathway, specifically under the Traditional review type, and was determined to be *substantially equivalent* to a predicate device. It is classified as a Class II medical device and falls under the Dental advisory committee (DE) category, with a product code of ELE.

• Are there different models or sizes of the Surgical Vitex, and how might a clinician choose between them?

  The Surgical Vitex comes in varying mesh sizes (20-40 or 40-60), which influence whether it is reusable or single-use. Clinicians would select the appropriate mesh size based on the specific surgical requirements, patient anatomy, and whether the implant will be reused or discarded after a single procedure.