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
- 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 |