Ortho Organizers, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Ortho Organizers, Inc.” (first 1993, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 113 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 257 |
| 2017 | 0 | — |
| 2018 | 1 | 122 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ortho Organizers, Inc. took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | 2 | 2 |
| EJF | Bracket, Metal, Orthodontic | 2 | 2 |
| NJM | Bracket, Ceramic, Orthodontic | 2 | 2 |
| DYO | Band, Material, Orthodontic | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
Review panels
- Dental (8)
Most recent Ortho Organizers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | DYW | 2025-11-27 | 90 |
| K173440 | Carriere SLX 3D Clear | NJM | 2018-03-08 | 122 |
| K160720 | Carriere Motion Clear Class II | DYW | 2016-11-28 | 257 |
| K110335 | CERAMIC BRACKETS | NJM | 2011-05-19 | 104 |
| K061266 | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR | OAT | 2006-07-31 | 87 |
| K923218 | NITANIUM PALATAL EXPANDER | EJF | 1993-09-13 | 439 |
| K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS | DYO | 1993-09-01 | 132 |
| K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | EJF | 1993-07-08 | 94 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-04-02.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ortho Diagnostic Systems, Inc. (126 510(k)s)
- Ortho Development Corp. (64 510(k)s)
- Ortho Diagnostics, Inc. (24 510(k)s)
- Ortho Tec, LLC (22 510(k)s)
- Ortho Clinical Diagnostics (16 510(k)s)
- Ortho Pharmaceutical Corp. (9 510(k)s)
- Ortho Source (9 510(k)s)
- Ortho Kinetics Corp. (7 510(k)s)
- Ortho Instruments (6 510(k)s)
- Ortho Kinematics, Inc. (6 510(k)s)
- Ortho Solutions Limited (6 510(k)s)
- Ortho Pared Instruments, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ortho Organizers, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Ortho Organizers, Inc.” (first 1993, latest 2025), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ortho Organizers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho Organizers, Inc. is 113 days.
Which FDA product codes appear under Ortho Organizers, Inc.?
The most frequent FDA product codes under this applicant name are DYW (Bracket, Plastic, Orthodontic, 2); EJF (Bracket, Metal, Orthodontic, 2); NJM (Bracket, Ceramic, Orthodontic, 2).
Next steps
- See all 8 Ortho Organizers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYW, Ortho Organizers, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.