DZB — Headgear, Extraoral, Orthodontic Class II
FDA product code DZB covers "Headgear, Extraoral, Orthodontic", a Class II medical device regulated under 21 CFR 872.5500. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DZB
- Device Class
- Class II
- Regulation Number
- 872.5500
- Submission Type
- 510(k)
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K202855 | Ita.O Italian Orthodontic System | Orthodontic Facemask | Jun 21, 2021 |
| K162543 | Sawbros Industries Pvt | Reverse Pull Adjustable Facemask | Aug 28, 2017 |
| K111169 | Kwang Myung Daicom | PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM… | Oct 3, 2011 |
| K103019 | Kj Meditech Co | KJ MASK | Jun 9, 2011 |
| K052553 | Russell Samuels Orthodontic Design | NITOM LOCKING FACEBOW | Dec 22, 2005 |
| K051751 | Ortho Technology | EQUA-PULL SAFETY RELEASE MODULE | Jul 22, 2005 |
| K041718 | Great Lakes Orthodontics | KELES FACEMASK | Oct 15, 2004 |
| K032392 | Ortosim, S.A. De C.V | MORALES PROTRACTION FACEMASK | Oct 22, 2003 |
| K000358 | Ortho Technology | MULTI ADJUSTABLE FACE MASK | Jun 9, 2000 |
| K993224 | Dontech Products | T-GEAR, MODEL TG/400-700 | Feb 11, 2000 |
| K982088 | Ortho Kinetics | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | Sep 4, 1998 |
| K980436 | Ortho Kinetics | CLASS III REVERSE PULL FACEMASK | Apr 27, 1998 |
| K980245 | Ortho Kinetics | NITOM LOCKING FACEBOW | Apr 21, 1998 |
| K980151 | Ortho Kinetics | RELEASABLE FORCE MODULE | Apr 6, 1998 |
| K980195 | Ortho Kinetics | FACEBOW | Mar 11, 1998 |
| K961754 | G And H Wire | SAFETY RELEASE MODULE | Jul 10, 1996 |
| K955528 | Clp Products | CLP BONNET | Feb 14, 1996 |
| K950121 | France Orthodontie | FRANCE ORTHODONTIE | Mar 8, 1995 |
| K936151 | Dentauraum | EXTRAORAL HEADGEAR | Aug 1, 1994 |
| K940410 | Ortho Kinetics | NEW GEAR RELEASABLE HEADGEAR | Mar 10, 1994 |