Cleared Traditional

K162543 - Reverse Pull Adjustable Facemask

K162543 is an FDA 510(k) clearance for Reverse Pull Adjustable Facemask, manufactured by Sawbros Industries Pvt., Ltd.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K162543 · Sawbros Industries Pvt., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
350d
Days
Class 2
Risk

K162543 is an FDA 510(k) clearance for the Reverse Pull Adjustable Facemask. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Sawbros Industries Pvt., Ltd. (Noida, IN). The FDA issued a Cleared decision on August 28, 2017 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sawbros Industries Pvt., Ltd. devices

FDA 510(k) Submission Details - K162543

510(k) Number K162543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2016
Decision Date August 28, 2017
Days to Decision 350 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 127d · This submission: 350d
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 Peers - DZB Headgear, Extraoral, Orthodontic

Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K162543.
Orthodontic Facemask
K202855 · Ita.O Italian Orthodontic System S.R.L. · Jun 2021
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