Multi-Adjustable Facemask 426-055
Multi-Adjustable Facemask 426-055 is a Class II device made by Ortho Organizers, Inc., cleared under FDA 510(k) K000358 on 9 Jun 2000 and listed in FDA GUDID since 6 Jan 2022 (UDI-DI 00190707097684), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00190707097684 | Date6 Jan 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK000358 | Date9 Jun 2000 | StatusActive |
Official records
- AccessGUDID record 00190707097684
- FDA 510(k) database K000358
Across registries
- FDA 510(k) K000358 decided 9 Jun 2000 Active
- FDA GUDID UDI-DI 00190707097684 listed 6 Jan 2022 Listed
Timeline
- Cleared FDA 510(k) K000358
- Listed FDA GUDID 00190707097684
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Multi-Adjustable Facemask
- Generic name
- Orthodontic extraoral headgear
- Model / reference
- 426-055
- Primary DI / UDI-DI
- 00190707097684
- 510(k) Number
- FDA product code
- DZB
- GMDN term
- Orthodontic extraoral headgear
- Device class
- Class II
- Regulation number
- 872.5500
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthodontic extraoral headgear.