Sdi Limited: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sdi Limited” (first 2010, latest 2022), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 114 days. Since 2017 the median was 164 days, against 115 days for all cleared 510(k)s in the same product codes. 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 | 1 | 279 |
| 2019 | 1 | 164 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 3 | 63 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sdi Limited took a median 164 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| EMA | Cement, Dental | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
| PHR | Diammine Silver Fluoride Dental Hypersensitivity Varnish | 1 | 1 |
Review panels
- Dental (6)
Most recent Sdi Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222583 | Stela Capsule System | EBF | 2022-10-28 | 63 |
| K222581 | Stela Automix System | EBF | 2022-10-28 | 63 |
| K214118 | Riva Cem Automix | EMA | 2022-08-30 | 243 |
| K191656 | Zipbond | KLE | 2019-12-02 | 164 |
| K172047 | Riva Star | PHR | 2018-04-11 | 279 |
| K102984 | AURA | EBF | 2010-12-08 | 62 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-07-20.
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 Sdi Limited?
FDA lists 6 510(k) clearances under the applicant name “Sdi Limited” (first 2010, latest 2022), 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 Sdi Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sdi Limited is 114 days. Since 2017: 164 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sdi Limited?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 3); EMA (Cement, Dental, 1); KLE (Agent, Tooth Bonding, Resin, 1).
Next steps
- See all 6 Sdi Limited clearances with predicates and recalls
- Run predicate analysis for product code EBF, Sdi 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.