Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tp Orthodontics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
342 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics | Tp Orthodontics, Inc. | 2022-10-14 | 291 | 0 |
| K193385 | TP Orthodontics Clear Aligner System | Tp Orthodontics, Inc. | 2020-11-12 | 342 | 0 |
| K111234 | CLICK-IT | Tp Orthodontics, Inc. | 2011-05-13 | 11 | 0 |
| K952643 | RIGHT-ON ADHESIVE BOUDING SYSTEM | Tp Orthodontics, Inc. | 1995-07-11 | 32 | 0 |
| K950992 | CERAMAFLEX BRACKET SYSTEM | Tp Orthodontics, Inc. | 1995-05-03 | 61 | 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