DZB · Class II · 21 CFR 872.5500

FDA Product Code DZB: Headgear, Extraoral, Orthodontic

Leading manufacturers include Ortho Kinetics Corp., Ormco Corp. and Ortho Technology.

36

Total

36

Cleared

99d

Avg days

1977

Since

FDA 510(k) Cleared Headgear, Extraoral, Orthodontic Devices (Product Code DZB)

36 devices

1–24 of 36

Cleared Jun 21, 2021

Orthodontic Facemask

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

Cleared Aug 28, 2017

Reverse Pull Adjustable Facemask

Sawbros Industries Pvt., Ltd.

Cleared Oct 03, 2011

PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF

Kwang Myung Daicom, Inc.

Cleared Jun 09, 2011

Kj Meditech Co., Ltd.

Cleared Dec 22, 2005

NITOM LOCKING FACEBOW

Russell Samuels Orthodontic Design

Cleared Jul 22, 2005

EQUA-PULL SAFETY RELEASE MODULE

Ortho Technology

Cleared Oct 15, 2004

Great Lakes Orthodontics, Ltd.

Cleared Oct 22, 2003

MORALES PROTRACTION FACEMASK

Ortosim, S.A. DE C.V.

Cleared Jun 09, 2000

MULTI ADJUSTABLE FACE MASK

Ortho Technology

Cleared Feb 11, 2000

T-GEAR, MODEL TG/400-700

Dontech Products B.V.

Cleared Sep 04, 1998

AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM

Ortho Kinetics Corp.

Cleared Apr 27, 1998

CLASS III REVERSE PULL FACEMASK

Ortho Kinetics Corp.

Cleared Apr 21, 1998

NITOM LOCKING FACEBOW

Ortho Kinetics Corp.

Cleared Apr 06, 1998

RELEASABLE FORCE MODULE

Ortho Kinetics Corp.

Cleared Mar 11, 1998

Ortho Kinetics Corp.

Cleared Jul 10, 1996

SAFETY RELEASE MODULE

Cleared Feb 14, 1996

Cleared Aug 01, 1994

EXTRAORAL HEADGEAR

Dentauraum, Inc.

Cleared Dec 04, 1992

Cleared Sep 06, 1990

HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL

Cleared Sep 06, 1990

HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP

Cleared Jul 11, 1986

SENTRY BREAKWAY NECK STRAP

About Product Code DZB - Regulatory Context

Related FDA 510(k) Regulatory Insights