Cleared Traditional

K202855 - Orthodontic Facemask
(FDA 510(k) Clearance)

K202855 · Ita.O Italian Orthodontic System S.R.L. · Dental

Jun 2021

Decision

266d

Days

Class 2

Risk

K202855 is an FDA 510(k) clearance for the Orthodontic Facemask. This device is classified as a Headgear, Extraoral, Orthodontic (Class II — Special Controls, product code DZB).

Submitted by Ita.O Italian Orthodontic System S.R.L. (Villanova Di Castenaso, IT). The FDA issued a Cleared decision on June 21, 2021, 266 days after receiving the submission on September 28, 2020.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5500.

Submission Details

510(k) Number	K202855 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2020
Decision Date	June 21, 2021
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement