First Scientific Limited: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “First Scientific Limited” (first 2001, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (5)
Most recent First Scientific Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011521 | ORTHO VLC; ORTHO VLC CAPSULE | DYH | 2001-08-01 | 76 |
| K011520 | RESTORE-X | EMA | 2001-07-23 | 67 |
| K011517 | LUTE; CORE | EBF | 2001-07-10 | 54 |
| K011295 | RESTORE-PF VIC; RESTORE-PF VLC CAPSULE | EBF | 2001-06-27 | 58 |
| K011309 | LUTE VLC; CORE VLC | EBF | 2001-06-22 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named First Scientific Limited.
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.
- First Quality Hygienic, Inc. (11 510(k)s)
- First Medical Devices Corp. (7 510(k)s)
- First Industries, Inc. (6 510(k)s)
- First Medical, Inc. (4 510(k)s)
- First Ray, LLC (4 510(k)s)
- First Source, Inc. (3 510(k)s)
- First Light Diagnostics, Inc. (2 510(k)s)
- First Sense Medical, LLC (2 510(k)s)
- First Touch Disposables, Inc. (2 510(k)s)
- First Call, Inc. (1 510(k)s)
- First Check Diagnostics, LLC (1 510(k)s)
- First Glove Sdn. Bhd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under First Scientific Limited?
FDA lists 5 510(k) clearances under the applicant name “First Scientific Limited” (first 2001, latest 2001), across 3 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 First Scientific Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name First Scientific Limited is 58 days.
Which FDA product codes appear under First Scientific Limited?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 3); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1); EMA (Cement, Dental, 1).
Next steps
- See all 5 First Scientific Limited clearances with predicates and recalls
- Run predicate analysis for product code EBF, First Scientific Limited'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.