The S. S. White Co.: FDA clearances and approvals
The S. S. White Co. has 14 FDA 510(k) clearances (first 1976, latest 1985), across 9 product codes in 2 review panels. Median 510(k) review time: 25 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 4 | 4 |
| EAP | Unit, X-Ray, Intraoral | 1 | 1 |
| EBH | Material, Impression Tray, Resin | 1 | 1 |
| EGZ | Holder, Film, X-Ray | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
| EJL | Bur, Dental | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
| KLC | Chair, Dental, With Operative Unit | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent The S. S. White Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852745 | PORCELAIN VENEER SYSTEM BONDING KIT | EBF | 1985-08-16 | 50 |
| K852744 | CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR | EBF | 1985-08-16 | 50 |
| K853005 | S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM | EGZ | 1985-08-13 | 28 |
| K852743 | PORCELAIN VENEER SYSTEM LABORATORY KIT | EIH | 1985-07-31 | 34 |
| K852182 | EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER | EBH | 1985-07-02 | 43 |
| K837440 | UNKNOWN | — | 1983-06-10 | 66 |
| K827816 | PODIATRY X-RAY UNIT | — | 1982-08-24 | 29 |
| K781293 | RESTORATIVE SYSTEM PROFILE | EBF | 1978-08-18 | 22 |
| K771938 | ALGINATE IMPRESSION MATERIAL | ELW | 1977-11-02 | 16 |
| K770093 | DENTAL BURS | EJL | 1977-01-24 | 7 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The S. S. White Co..
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 The S. S. White Co. have?
The S. S. White Co. has 14 FDA 510(k) clearances (first 1976, latest 1985), across 9 product codes in 2 review panels.
How long does FDA take to clear The S. S. White Co.'s 510(k)s?
The median time from FDA receipt to decision across The S. S. White Co.'s cleared 510(k)s is 25 days.
What devices does The S. S. White Co. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 4); EAP (Unit, X-Ray, Intraoral, 1); EBH (Material, Impression Tray, Resin, 1).
Has The S. S. White Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching The S. S. White Co. Related entities may recall under other names.
Next steps
- See all 14 The S. S. White Co. clearances with predicates and recalls
- Run predicate analysis for product code EBF, The S. S. White Co.'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.