DZB · Headgear, Extraoral, Orthodontic
Dental · 21 CFR 872.5500 · Class 2
Overview
| Product Code | DZB |
|---|---|
| Device Name | Headgear, Extraoral, Orthodontic |
| Regulation | 21 CFR 872.5500 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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.
Cleared Devices (36)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202855 | Orthodontic Facemask | Ita.O Italian Orthodontic System S.R.L. | Jun 21, 2021 | SESE |
| K162543 | Reverse Pull Adjustable Facemask | Sawbros Industries Pvt., Ltd. | Aug 28, 2017 | SESE |
| K111169 | 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 | KJ MASK | Kj Meditech Co., Ltd. | Jun 9, 2011 | SESE |
| K052553 | NITOM LOCKING FACEBOW | Russell Samuels Orthodontic Design | Dec 22, 2005 | SESE |
| K051751 | EQUA-PULL SAFETY RELEASE MODULE | Ortho Technology | Jul 22, 2005 | SESE |
| K041718 | KELES FACEMASK | Great Lakes Orthodontics, Ltd. | Oct 15, 2004 | SESE |
| K032392 | MORALES PROTRACTION FACEMASK | Ortosim, S.A. DE C.V. | Oct 22, 2003 | SESE |
| K000358 | MULTI ADJUSTABLE FACE MASK | Ortho Technology | Jun 9, 2000 | SESE |
| K993224 | T-GEAR, MODEL TG/400-700 | Dontech Products B.V. | Feb 11, 2000 | SESE |
| K982088 | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | Ortho Kinetics Corp. | Sep 4, 1998 | SESE |
| K980436 | CLASS III REVERSE PULL FACEMASK | Ortho Kinetics Corp. | Apr 27, 1998 | SESE |
| K980245 | NITOM LOCKING FACEBOW | Ortho Kinetics Corp. | Apr 21, 1998 | SESE |
| K980151 | RELEASABLE FORCE MODULE | Ortho Kinetics Corp. | Apr 6, 1998 | SESE |
| K980195 | FACEBOW | Ortho Kinetics Corp. | Mar 11, 1998 | SESE |
| K961754 | SAFETY RELEASE MODULE | G & H Wire Co. | Jul 10, 1996 | SESE |
| K955528 | CLP BONNET | Clp Products | Feb 14, 1996 | SESE |
| K950121 | FRANCE ORTHODONTIE | France Orthodontie | Mar 8, 1995 | SESE |
| K936151 | EXTRAORAL HEADGEAR | Dentauraum, Inc. | Aug 1, 1994 | SESE |
| K940410 | NEW GEAR RELEASABLE HEADGEAR | Ortho Kinetics Corp. | Mar 10, 1994 | SESE |
| K932761 | SOFT-WEAR HEADGEAR AND SAFETY MODULES | Professional Positioners, Inc. | Oct 7, 1993 | SESE |
| K925240 | FACEBOW | Forestadent Bernhard Forster GmbH | Jun 18, 1993 | SESE |
| K923556 | ADP FACEMASK | Ormco Corp. | Dec 4, 1992 | SESE |
| K920784 | ORTHODONTIC FACE BOW W/ INNER WIRE | Gac Intl., Inc. | Mar 20, 1992 | SESE |
| K912682 | ORTHODONTIC HEADGEAR | K-Tek Orthodontic Products | Dec 9, 1991 | SESE |
| K902646 | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP | Ormco Corp. | Sep 6, 1990 | SESE |
| K902645 | HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL | Ormco Corp. | Sep 6, 1990 | SESE |
| K901958 | GUARDIAN SAFE BOW | Lancer Orthodontics, Inc. | Jul 30, 1990 | SESE |
| K862538 | SENTRY BREAKWAY NECK STRAP | Ormco Corp. | Jul 11, 1986 | SESE |
| K861424 | ADAPTABLE CLASS III MASK | Great Lakes Orthodontics, Ltd. | May 29, 1986 | SESE |
| K852670 | A-COMPANY ESPREE SAFETY HEADGEAR | A Company, Inc. | Jul 31, 1985 | SESE |
| K800748 | SNAP-WAY HEADGEAR | Northwest Orthodontics, Inc. | Apr 10, 1980 | SESE |
| K790843 | SNAP-WAY | Northwest Orthodontics, Inc. | May 31, 1979 | SESE |
| K780747 | SNAP-WAY | Northwest Orthodontics, Inc. | May 26, 1978 | SESE |
| K771706 | SAIF-BOW | Northwest Orthodontics, Inc. | Sep 20, 1977 | SESE |
| K771095 | J HOOK HEADGEAR | Northwest Orthodontics, Inc. | Jun 24, 1977 | SESE |
Top Applicants
- Ortho Kinetics Corp. — 6 clearances
- Northwest Orthodontics, Inc. — 5 clearances
- Ormco Corp. — 4 clearances
- Ortho Technology — 2 clearances
- Great Lakes Orthodontics, Ltd. — 2 clearances
