FDA Product Code
FDA Product Code DZB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5500
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K202855 | Orthodontic Facemask | Ita.O Italian Orthodontic System S.R.L. | 2021-06-21 | Traditional | PDF ↗ |
| K162543 | Reverse Pull Adjustable Facemask | Sawbros Industries Pvt., Ltd. | 2017-08-28 | Traditional | PDF ↗ |
| 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. | 2011-10-03 | Traditional | PDF ↗ |
| K103019 | KJ MASK | Kj Meditech Co., Ltd. | 2011-06-09 | Traditional | PDF ↗ |
| K052553 | NITOM LOCKING FACEBOW | Russell Samuels Orthodontic Design | 2005-12-22 | Traditional | PDF ↗ |
| K051751 | EQUA-PULL SAFETY RELEASE MODULE | Ortho Technology | 2005-07-22 | Traditional | PDF ↗ |
| K041718 | KELES FACEMASK | Great Lakes Orthodontics, Ltd. | 2004-10-15 | Traditional | PDF ↗ |
| K032392 | MORALES PROTRACTION FACEMASK | Ortosim, S.A. DE C.V. | 2003-10-22 | Traditional | PDF ↗ |
| K000358 | MULTI ADJUSTABLE FACE MASK | Ortho Technology | 2000-06-09 | Traditional | PDF ↗ |
| K993224 | T-GEAR, MODEL TG/400-700 | Dontech Products B.V. | 2000-02-11 | Traditional | PDF ↗ |
| K982088 | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | Ortho Kinetics Corp. | 1998-09-04 | Traditional | PDF ↗ |
| K980436 | CLASS III REVERSE PULL FACEMASK | Ortho Kinetics Corp. | 1998-04-27 | Traditional | PDF ↗ |
| K980245 | NITOM LOCKING FACEBOW | Ortho Kinetics Corp. | 1998-04-21 | Traditional | PDF ↗ |
| K980151 | RELEASABLE FORCE MODULE | Ortho Kinetics Corp. | 1998-04-06 | Traditional | PDF ↗ |
| K980195 | FACEBOW | Ortho Kinetics Corp. | 1998-03-11 | Traditional | PDF ↗ |
| K961754 | SAFETY RELEASE MODULE | G & H Wire Co. | 1996-07-10 | Traditional | PDF ↗ |
| K955528 | CLP BONNET | Clp Products | 1996-02-14 | Traditional | PDF ↗ |
| K950121 | FRANCE ORTHODONTIE | France Orthodontie | 1995-03-08 | Traditional | PDF ↗ |
| K936151 | EXTRAORAL HEADGEAR | Dentauraum, Inc. | 1994-08-01 | Traditional | PDF ↗ |
| K940410 | NEW GEAR RELEASABLE HEADGEAR | Ortho Kinetics Corp. | 1994-03-10 | Traditional | PDF ↗ |
| K932761 | SOFT-WEAR HEADGEAR AND SAFETY MODULES | Professional Positioners, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K925240 | FACEBOW | Forestadent Bernhard Forster GmbH | 1993-06-18 | Traditional | PDF ↗ |
| K923556 | ADP FACEMASK | Ormco Corp. | 1992-12-04 | Traditional | PDF ↗ |
| K920784 | ORTHODONTIC FACE BOW W/ INNER WIRE | Gac Intl., Inc. | 1992-03-20 | Traditional | PDF ↗ |
| K912682 | ORTHODONTIC HEADGEAR | K-Tek Orthodontic Products | 1991-12-09 | Traditional | PDF ↗ |
| K902646 | HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP | Ormco Corp. | 1990-09-06 | Traditional | PDF ↗ |
| K902645 | HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL | Ormco Corp. | 1990-09-06 | Traditional | PDF ↗ |
| K901958 | GUARDIAN SAFE BOW | Lancer Orthodontics, Inc. | 1990-07-30 | Traditional | PDF ↗ |
| K862538 | SENTRY BREAKWAY NECK STRAP | Ormco Corp. | 1986-07-11 | Traditional | PDF ↗ |
| K861424 | ADAPTABLE CLASS III MASK | Great Lakes Orthodontics, Ltd. | 1986-05-29 | Traditional | PDF ↗ |
| K852670 | A-COMPANY ESPREE SAFETY HEADGEAR | A Company, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K800748 | SNAP-WAY HEADGEAR | Northwest Orthodontics, Inc. | 1980-04-10 | Traditional | PDF ↗ |
| K790843 | SNAP-WAY | Northwest Orthodontics, Inc. | 1979-05-31 | Traditional | PDF ↗ |
| K780747 | SNAP-WAY | Northwest Orthodontics, Inc. | 1978-05-26 | Traditional | PDF ↗ |
| K771706 | SAIF-BOW | Northwest Orthodontics, Inc. | 1977-09-20 | Traditional | PDF ↗ |
| K771095 | J HOOK HEADGEAR | Northwest Orthodontics, Inc. | 1977-06-24 | Traditional | PDF ↗ |
Product code DZB · Class II · Dental. Data: openFDA.