V-Gnathos Supra

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K013769 ↗

FDA Product Code

EJT

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Aurofluid Plus

  Class II

  FDA 510(k) K013505 Active Cleared 19 Dec 2001

• Yellow Special

  Class II

  FDA 510(k) K013506 Active Cleared 3 Jan 2002

• XeraFit

  Class II

  FDA 510(k) K020062 Active Cleared 14 Feb 2002

• What types of dental or maxillofacial issues can the V-Gnathos Supra help address, and how does it function in treatment?

  The V-Gnathos Supra is designed to address jaw alignment, bite discrepancies, and skeletal discrepancies in orthodontic or maxillofacial treatment. It functions as a removable or fixed orthodontic appliance made from gold-based noble metal alloys, allowing for precise adjustments to correct misalignments or structural issues in the jaw.

• Is the V-Gnathos Supra intended for single-use or reusable applications, and what does this mean for clinical workflows?

  The V-Gnathos Supra is explicitly supplied as a reusable appliance, meaning it is intended for repeated use in clinical settings like dental offices. This design reduces waste and cost per patient while requiring proper cleaning and maintenance protocols to ensure hygiene and longevity between uses.

• How should the V-Gnathos Supra be stored, and are there any special considerations for its maintenance?

  Since the device is reusable and non-sterile, it should be stored in a clean, dry environment to prevent contamination or damage. Clinical staff must follow manufacturer-recommended cleaning and sterilization procedures (if applicable) between patient uses, though no specific sterility requirements are mentioned in the data. Proper storage also involves protecting it from physical wear or exposure to corrosive substances.

• What regulatory pathway was followed for the V-Gnathos Supra, and how does this affect its use in dental practices?

  The V-Gnathos Supra received a Traditional 510(k) clearance from the FDA in 2002, demonstrating it is classified as Device Class II under regulation number 872.3060. This means it is considered substantially equivalent to a predicate device and is legally marketed for orthodontic/maxillofacial applications. Practices using it must adhere to FDA compliance standards for dental appliances, including record-keeping and proper handling.

• Are there different sizes or models of the V-Gnathos Supra, and how might a clinician determine the appropriate fit for a patient?

  While the provided data does not specify exact sizes or model variations, the V-Gnathos Supra is designed as a customizable orthodontic appliance tailored to individual patient anatomy. Clinicians would typically rely on patient-specific impressions, measurements, or manufacturer guidance (e.g., sizing charts or fabrication instructions) to select or fabricate the correct configuration for jaw alignment or bite correction.