Keles Facemask

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

510(k) Number

K041718 ↗

FDA Product Code

DZB

Device Class

Class II

Regulation

21 CFR Part 872.5500

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Snore-No-More

  Class II

  FDA 510(k) K922818 Active Cleared 9 Feb 1994

• Oral Safe

  Class I

  FDA 510(k) K840805 Active Cleared 30 Mar 1984

• Variflex

  Class II

  FDA 510(k) K033632 Active Cleared 21 Jan 2004

• Exceed Tx Orthodontic Bracket

  Class II

  FDA 510(k) K150702 Active Cleared 24 Mar 2016

• Smart Moves Complete

  Class II

  FDA 510(k) K172765 Active Cleared 1 Jun 2018

• Steady Resin

  Class II

  FDA 510(k) K870908 Active Cleared 19 Mar 1987

See all devices from Great Lakes Orthodontics, Ltd. →

• What specific dental conditions is the Keles Facemask designed to address, and how does it work?

  The Keles Facemask is specifically designed to correct Class III dental malocclusions, where the lower jaw (mandible) protrudes beyond the upper jaw (maxilla). It applies controlled external forces to the maxilla, promoting its downward and forward rotation to improve alignment of the teeth and jaw structure. This extraoral orthodontic headgear is used under professional supervision in dental settings to guide proper jaw development.

• Is the Keles Facemask reusable, and what maintenance or cleaning instructions should be followed?

  Yes, the Keles Facemask is supplied as a reusable orthodontic appliance. Since it is intended for professional use in dental settings, it should be cleaned and disinfected according to standard dental practice protocols to ensure patient safety and device longevity. The manufacturer recommends following established sterilization or disinfection guidelines for orthodontic appliances.

• How is the Keles Facemask regulated, and what does its FDA clearance status mean for clinicians?

  The Keles Facemask holds FDA 510(k) clearance (K041718) under the DZB product code, classified as a Class II medical device (Dental, Extraoral Headgear). This clearance indicates it was determined to be substantially equivalent to legally marketed predecessors, meaning it meets FDA safety and effectiveness requirements for its intended use. Clinicians can rely on this status as evidence of regulatory review for its orthodontic application.

• Are there multiple sizes or models of the Keles Facemask, and how would a clinician determine the appropriate fit for a patient?

  The Keles Facemask is available in multiple sizes and models, as indicated by the diverse registration numbers (e.g., 3001778198, 3016543896, etc.) in the FDA database. The correct size and model should be selected based on the patient’s age, facial structure, and specific Class III malocclusion severity, with adjustments made by an orthodontist during fitting. The manufacturer’s sizing guides or professional consultation should be referenced to ensure proper application.