Company · US
Ortho Organizers, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (1 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 27, 2025 | K252760 | Carriere® Motion Pro® Clear Bite Corrector Ortho Organizers, Inc. | DYW |
| Mar 8, 2018 | K173440 | Carriere SLX 3D Clear Ortho Organizers, Inc. | NJM |
| Nov 28, 2016 | K160720 | Carriere Motion Clear Class II Ortho Organizers, Inc. | DYW |
| May 19, 2011 | K110335 | CERAMIC BRACKETS Ortho Organizers, Inc. | NJM |
| Jul 31, 2006 | K061266 | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR Ortho Organizers, Inc. | OAT |
| Sep 13, 1993 | K923218 | NITANIUM PALATAL EXPANDER Ortho Organizers, Inc. | EJF |
| Sep 1, 1993 | K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS Ortho Organizers, Inc. | DYO |
| Jul 8, 1993 | K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL Ortho Organizers, Inc. | EJF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2019 | Ortho Organizers, Inc. Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only
(01)00190707017064 (10)889437 (422)484
Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only
(01)00190707017071(10)889437 (422)484 Terminated |
EJF | None listed |
| Apr 2, 2019 | Ortho Organizers, Inc. Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only
(01)00190707016517 (10)112233 (422)484 Terminated |
EJF | None listed |
| Feb 15, 2011 | Ortho Organizers Inc ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each);
ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB U Terminated |
DZD | None listed |