Opusdent , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Opusdent , Ltd.” (first 2000, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 85 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
Review panels
Most recent Opusdent , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021508 | OPUSDUO EC DENTAL LASER SYSTEM | GEX | 2002-08-07 | 90 |
| K014100 | OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND | GEX | 2002-01-08 | 26 |
| K011769 | OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND | GEX | 2001-08-30 | 84 |
| K002899 | OPUS 20, MODEL 1ST | GEX | 2000-12-12 | 85 |
| K000990 | OPUS 10 DENTAL DIODE LASER | GEX | 2000-06-23 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Opusdent , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Opusdent , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Opusdent , Ltd.” (first 2000, latest 2002), across 1 product code 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 Opusdent , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Opusdent , Ltd. is 85 days.
Which FDA product codes appear under Opusdent , Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5).
Next steps
- See all 5 Opusdent , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Opusdent , Ltd.'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.