DZB — Headgear, Extraoral, Orthodontic Class II
FDA Device Classification
Classification Details
- Product Code
- DZB
- Device Class
- Class II
- Regulation Number
- 872.5500
- Submission Type
- 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 | June 21, 2021 |
| K162543 | sawbros industries pvt | Reverse Pull Adjustable Facemask | August 28, 2017 |
| K111169 | kwang myung daicom | PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-P | October 3, 2011 |
| K103019 | kj meditech co | KJ MASK | June 9, 2011 |
| K052553 | russell samuels orthodontic design | NITOM LOCKING FACEBOW | December 22, 2005 |
| K051751 | ortho technology | EQUA-PULL SAFETY RELEASE MODULE | July 22, 2005 |
| K041718 | great lakes orthodontics | KELES FACEMASK | October 15, 2004 |
| K032392 | ortosim, s.a. de c.v | MORALES PROTRACTION FACEMASK | October 22, 2003 |
| K000358 | ortho technology | MULTI ADJUSTABLE FACE MASK | June 9, 2000 |
| K993224 | dontech products | T-GEAR, MODEL TG/400-700 | February 11, 2000 |
| K982088 | ortho kinetics | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | September 4, 1998 |
| K980436 | ortho kinetics | CLASS III REVERSE PULL FACEMASK | April 27, 1998 |
| K980245 | ortho kinetics | NITOM LOCKING FACEBOW | April 21, 1998 |
| K980151 | ortho kinetics | RELEASABLE FORCE MODULE | April 6, 1998 |
| K980195 | ortho kinetics | FACEBOW | March 11, 1998 |
| K961754 | g and h wire | SAFETY RELEASE MODULE | July 10, 1996 |
| K955528 | clp products | CLP BONNET | February 14, 1996 |
| K950121 | france orthodontie | FRANCE ORTHODONTIE | March 8, 1995 |
| K936151 | dentauraum | EXTRAORAL HEADGEAR | August 1, 1994 |
| K940410 | ortho kinetics | NEW GEAR RELEASABLE HEADGEAR | March 10, 1994 |