Cleared Traditional

K202855 - Orthodontic Facemask

K202855 is an FDA 510(k) clearance for Orthodontic Facemask, manufactured by Ita.O Italian Orthodontic System S.R.L.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K202855 · Ita.O Italian Orthodontic System S.R.L. · Dental device
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Jun 2021
Decision
266d
Days
Class 2
Risk

K202855 is an FDA 510(k) clearance for the Orthodontic Facemask. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Ita.O Italian Orthodontic System S.R.L. (Villanova Di Castenaso, IT). The FDA issued a Cleared decision on June 21, 2021 after a review of 266 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5500 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ita.O Italian Orthodontic System S.R.L. devices

FDA 510(k) Submission Details - K202855

510(k) Number K202855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 127d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZB Device Classification - Class 2, Special Controls

Product Code DZB Headgear, Extraoral, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

THEMA S.r.l.
Marisa Testa

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZB Headgear, Extraoral, Orthodontic

Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K202855.
EXTRAORAL HEADGEAR
K936151 · Dentauraum, Inc. · Aug 1994
ADP FACEMASK
K923556 · Ormco Corp. · Dec 1992
HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL
K902645 · Ormco Corp. · Sep 1990
HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP
K902646 · Ormco Corp. · Sep 1990
SENTRY BREAKWAY NECK STRAP
K862538 · Ormco Corp. · Jul 1986