Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart F — Therapeutic Devices](/submissions/DE/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 872.5500](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5500) → DZB — Headgear, Extraoral, Orthodontic # DZB · Headgear, Extraoral, Orthodontic _Dental · 21 CFR 872.5500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB ## Overview - **Product Code:** DZB - **Device Name:** Headgear, Extraoral, Orthodontic - **Regulation:** [21 CFR 872.5500](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/872.5500) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 36) Showing 20 most recent of 36 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K202855](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K202855.md) | Orthodontic Facemask | Ita.O Italian Orthodontic System S.R.L. | Jun 21, 2021 | SESE | | [K162543](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K162543.md) | Reverse Pull Adjustable Facemask | Sawbros Industries Pvt., Ltd. | Aug 28, 2017 | SESE | | [K111169](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K111169.md) | 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. | Oct 3, 2011 | SESE | | [K103019](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K103019.md) | KJ MASK | Kj Meditech Co., Ltd. | Jun 9, 2011 | SESE | | [K052553](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K052553.md) | NITOM LOCKING FACEBOW | Russell Samuels Orthodontic Design | Dec 22, 2005 | SESE | | [K051751](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K051751.md) | EQUA-PULL SAFETY RELEASE MODULE | Ortho Technology | Jul 22, 2005 | SESE | | [K041718](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K041718.md) | KELES FACEMASK | Great Lakes Orthodontics, Ltd. | Oct 15, 2004 | SESE | | [K032392](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K032392.md) | MORALES PROTRACTION FACEMASK | Ortosim, S.A. DE C.V. | Oct 22, 2003 | SESE | | [K000358](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K000358.md) | MULTI ADJUSTABLE FACE MASK | Ortho Technology | Jun 9, 2000 | SESE | | [K993224](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K993224.md) | T-GEAR, MODEL TG/400-700 | Dontech Products B.V. | Feb 11, 2000 | SESE | | [K982088](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K982088.md) | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | Ortho Kinetics Corp. | Sep 4, 1998 | SESE | | [K980436](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K980436.md) | CLASS III REVERSE PULL FACEMASK | Ortho Kinetics Corp. | Apr 27, 1998 | SESE | | [K980245](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K980245.md) | NITOM LOCKING FACEBOW | Ortho Kinetics Corp. | Apr 21, 1998 | SESE | | [K980151](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K980151.md) | RELEASABLE FORCE MODULE | Ortho Kinetics Corp. | Apr 6, 1998 | SESE | | [K980195](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K980195.md) | FACEBOW | Ortho Kinetics Corp. | Mar 11, 1998 | SESE | | [K961754](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K961754.md) | SAFETY RELEASE MODULE | G & H Wire Co. | Jul 10, 1996 | SESE | | [K955528](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K955528.md) | CLP BONNET | Clp Products | Feb 14, 1996 | SESE | | [K950121](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K950121.md) | FRANCE ORTHODONTIE | France Orthodontie | Mar 8, 1995 | SESE | | [K936151](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K936151.md) | EXTRAORAL HEADGEAR | Dentauraum, Inc. | Aug 1, 1994 | SESE | | [K940410](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB/K940410.md) | NEW GEAR RELEASABLE HEADGEAR | Ortho Kinetics Corp. | Mar 10, 1994 | SESE | ## Top Applicants - Ortho Kinetics Corp. — 6 clearances - Northwest Orthodontics, Inc. — 5 clearances - Ormco Corp. — 4 clearances - Great Lakes Orthodontics, Ltd. — 2 clearances - Ortho Technology — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/DZB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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