Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ortho Organizers, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
439 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | 2025-11-27 | 90 | 0 |
| K173440 | Carriere SLX 3D Clear | Ortho Organizers, Inc. | 2018-03-08 | 122 | 0 |
| K160720 | Carriere Motion Clear Class II | Ortho Organizers, Inc. | 2016-11-28 | 257 | 0 |
| K110335 | CERAMIC BRACKETS | Ortho Organizers, Inc. | 2011-05-19 | 104 | 0 |
| K061266 | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR | Ortho Organizers, Inc. | 2006-07-31 | 87 | 0 |
| K923218 | NITANIUM PALATAL EXPANDER | Ortho Organizers, Inc. | 1993-09-13 | 439 | 0 |
| K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS | Ortho Organizers, Inc. | 1993-09-01 | 132 | 0 |
| K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | Ortho Organizers, Inc. | 1993-07-08 | 94 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda