Headgear, Extraoral, Orthodontic
Regulation 872.5500
0510(k)s in 12 months (36 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DZB
| Company | 510(k)s | Recalls |
|---|---|---|
| Ortho Kinetics Corp. | 6 | 0 |
| Northwest Orthodontics, Inc. | 5 | 0 |
| Ormco Corp. | 4 | 0 |
| Great Lakes Orthodontics, Ltd. | 2 | 0 |
| Ortho Technology | 2 | 0 |
| A Company, Inc. | 1 | 0 |
| Clp Products | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Dontech Products B.V. | 1 | 0 |
| Forestadent Bernhard Forster GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 2021 | K202855 | Orthodontic Facemask Ita.O Italian Orthodontic System S.R.L., IT | DZB |
| Aug 28, 2017 | K162543 | Reverse Pull Adjustable Facemask Sawbros Industries Pvt., Ltd., IN | DZB |
| Oct 3, 2011 | 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. | DZB |
| Jun 9, 2011 | K103019 | KJ MASK Kj Meditech Co., Ltd. | DZB |
| Dec 22, 2005 | K052553 | NITOM LOCKING FACEBOW Russell Samuels Orthodontic Design, GB | DZB |
| Jul 22, 2005 | K051751 | EQUA-PULL SAFETY RELEASE MODULE Ortho Technology | DZB |
| Oct 15, 2004 | K041718 | KELES FACEMASK Great Lakes Orthodontics, Ltd. | DZB |
| Oct 22, 2003 | K032392 | MORALES PROTRACTION FACEMASK Ortosim, S.A. DE C.V. | DZB |
| Jun 9, 2000 | K000358 | MULTI ADJUSTABLE FACE MASK Ortho Technology | DZB |
| Feb 11, 2000 | K993224 | T-GEAR, MODEL TG/400-700 Dontech Products B.V., NL | DZB |
| Sep 4, 1998 | K982088 | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM Ortho Kinetics Corp. | DZB |
| Apr 27, 1998 | K980436 | CLASS III REVERSE PULL FACEMASK Ortho Kinetics Corp. | DZB |
| Apr 21, 1998 | K980245 | NITOM LOCKING FACEBOW Ortho Kinetics Corp. | DZB |
| Apr 6, 1998 | K980151 | RELEASABLE FORCE MODULE Ortho Kinetics Corp. | DZB |
| Mar 11, 1998 | K980195 | FACEBOW Ortho Kinetics Corp. | DZB |
| Jul 10, 1996 | K961754 | SAFETY RELEASE MODULE G & H Wire Co. | DZB |
| Feb 14, 1996 | K955528 | CLP BONNET Clp Products | DZB |
| Mar 8, 1995 | K950121 | FRANCE ORTHODONTIE France Orthodontie, FR | DZB |
| Aug 1, 1994 | K936151 | EXTRAORAL HEADGEAR Dentauraum, Inc. | DZB |
| Mar 10, 1994 | K940410 | NEW GEAR RELEASABLE HEADGEAR Ortho Kinetics Corp. | DZB |
| Oct 7, 1993 | K932761 | SOFT-WEAR HEADGEAR AND SAFETY MODULES Professional Positioners, Inc. | DZB |
| Jun 18, 1993 | K925240 | FACEBOW Forestadent Bernhard Forster GmbH, GR | DZB |
| Dec 4, 1992 | K923556 | ADP FACEMASK Ormco Corp. | DZB |
| Mar 20, 1992 | K920784 | ORTHODONTIC FACE BOW W/ INNER WIRE Gac Intl., Inc. | DZB |
| Dec 9, 1991 | K912682 | ORTHODONTIC HEADGEAR K-Tek Orthodontic Products | DZB |
| Sep 6, 1990 | K902646 | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP Ormco Corp. | DZB |
| Sep 6, 1990 | K902645 | HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL Ormco Corp. | DZB |
| Jul 30, 1990 | K901958 | GUARDIAN SAFE BOW Lancer Orthodontics, Inc. | DZB |
| Jul 11, 1986 | K862538 | SENTRY BREAKWAY NECK STRAP Ormco Corp. | DZB |
| May 29, 1986 | K861424 | ADAPTABLE CLASS III MASK Great Lakes Orthodontics, Ltd. | DZB |
| Jul 31, 1985 | K852670 | A-COMPANY ESPREE SAFETY HEADGEAR A Company, Inc. | DZB |
| Apr 10, 1980 | K800748 | SNAP-WAY HEADGEAR Northwest Orthodontics, Inc. | DZB |
| May 31, 1979 | K790843 | SNAP-WAY Northwest Orthodontics, Inc. | DZB |
| May 26, 1978 | K780747 | SNAP-WAY Northwest Orthodontics, Inc. | DZB |
| Sep 20, 1977 | K771706 | SAIF-BOW Northwest Orthodontics, Inc. | DZB |
| Jun 24, 1977 | K771095 | J HOOK HEADGEAR Northwest Orthodontics, Inc. | DZB |
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