Ortho Source: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Ortho Source” (first 1986, latest 1992), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 63 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 | 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 5 | 5 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (9)
Most recent Ortho Source 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913853 | FISSURE SEALER | EBC | 1992-08-27 | 366 |
| K913854 | ORTHO LIGHT CURE | DYH | 1992-01-14 | 140 |
| K913519 | SUMO GLASS IONOMER CEMENT | EMA | 1991-11-19 | 104 |
| K884949 | VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER | EJK | 1989-02-23 | 90 |
| K884575 | MAXIBOND | DYH | 1989-01-03 | 63 |
| K861118 | ORTHOJOIN, ORTHODONTIC ADHESIVE | DYH | 1986-05-02 | 38 |
| K861258 | PERMABAND (ORTHODONTIC ADHESIVE) | DYH | 1986-04-17 | 14 |
| K861245 | ORTHOSOURCE ETCH SYSTEMS | EBC | 1986-04-11 | 9 |
| K860959 | DEPENDABOND | DYH | 1986-03-25 | 12 |
Recalls
openFDA lists no recalls under a recalling firm named Ortho Source.
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 Organizers, Inc. (8 510(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 Source?
FDA lists 9 510(k) clearances under the applicant name “Ortho Source” (first 1986, latest 1992), across 4 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 Source?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ortho Source is 63 days.
Which FDA product codes appear under Ortho Source?
The most frequent FDA product codes under this applicant name are DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 5); EBC (Sealant, Pit And Fissure, And Conditioner, 2); EJK (Liner, Cavity, Calcium Hydroxide, 1).
Next steps
- See all 9 Ortho Source clearances with predicates and recalls
- Run predicate analysis for product code DYH, Ortho Source'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.