Ortho Kinetics Corp.: FDA clearances and approvals
Ortho Kinetics Corp. has 7 FDA 510(k) clearances (first 1994, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time: 80 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZB | Headgear, Extraoral, Orthodontic | 6 | 6 |
| ECI | Band, Elastic, Orthodontic | 1 | 1 |
Review panels
- Dental (7)
Most recent Ortho Kinetics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982088 | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | DZB | 1998-09-04 | 81 |
| K980436 | CLASS III REVERSE PULL FACEMASK | DZB | 1998-04-27 | 82 |
| K980245 | NITOM LOCKING FACEBOW | DZB | 1998-04-21 | 88 |
| K980864 | POWER COINS GLOW IN THE DARK LIGATURES | ECI | 1998-04-20 | 46 |
| K980151 | RELEASABLE FORCE MODULE | DZB | 1998-04-06 | 80 |
| K980195 | FACEBOW | DZB | 1998-03-11 | 50 |
| K940410 | NEW GEAR RELEASABLE HEADGEAR | DZB | 1994-03-10 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Ortho Kinetics Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ortho Kinetics Corp. have?
Ortho Kinetics Corp. has 7 FDA 510(k) clearances (first 1994, latest 1998), across 2 product codes in 1 review panel.
How long does FDA take to clear Ortho Kinetics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Ortho Kinetics Corp.'s cleared 510(k)s is 80 days.
What devices does Ortho Kinetics Corp. make?
Its most frequent FDA product codes are DZB (Headgear, Extraoral, Orthodontic, 6); ECI (Band, Elastic, Orthodontic, 1).
Has Ortho Kinetics Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ortho Kinetics Corp. Related entities may recall under other names.
Next steps
- See all 7 Ortho Kinetics Corp. clearances with predicates and recalls
- Run predicate analysis for product code DZB, Ortho Kinetics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.