Orthodontic Facemask

by Ita.O Italian Orthodontic System S.R.L.

510(k) K202855

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

510(k) K202855↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK202855	Date21 Jun 2021Cleared	StatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K202855
FDA Product Code: DZB

Device Class: Class II
Regulation: 21 CFR Part 872.5500
Advisory Committee: Dental
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Orthodontic Facemask is an extraoral orthodontic headgear designed to apply external forces to the facial skeleton, aiding in the correction of dental and skeletal malocclusions. It is classified as a Class II device under FDA regulations and is used primarily in orthodontic treatment to manage transverse and sagittal discrepancies, including protraction of the maxilla or restriction of mandibular growth.

This device is supplied as a reusable, non-sterile orthodontic appliance and is intended for clinical use in dental offices or orthodontic practices. It is manufactured by Ita.O Italian Orthodontic System S.R.L. and has received FDA 510(k) clearance (K202855) under the Traditional review pathway. Multiple registration numbers (e.g., 3001778198) and product codes (DZB) further identify its regulatory classification under the medical specialty of dental care.