Orthodontic Facemask— 510(k) K202855

Name: FDA 510(k) clearance K202855
Creator: U.S. Food and Drug Administration
Published: 2021-06-21

Substantially Equivalent

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

FDA 510(k) clearance K202855 for Orthodontic Facemask, Substantially Equivalent on 2021-06-21. Applicant: Ita.O Italian Orthodontic System S.R.L.. Device class: 2.

Clearance details

Applicant: Ita.O Italian Orthodontic System S.R.L.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 2020-09-28
Decision date: 2021-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Villanova Di Castenaso, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZB

view all

K162543 — Reverse Pull Adjustable Facemask2017-08-28
K111169 — PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF2011-10-03
K103019 — KJ MASK2011-06-09
K052553 — NITOM LOCKING FACEBOW2005-12-22
K051751 — EQUA-PULL SAFETY RELEASE MODULE2005-07-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.