Scientific Pharmaceuticals, Inc.: FDA filings under this applicant name
FDA lists 73 510(k) clearances under the applicant name “Scientific Pharmaceuticals, Inc.” (first 1979, latest 2020), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 61 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 | 1 | 172 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Scientific Pharmaceuticals, Inc. took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 29 | 29 |
| EMA | Cement, Dental | 9 | 9 |
| LBH | Varnish, Cavity | 9 | 9 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 7 | 7 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 7 | 7 |
| EBD | Coating, Filling Material, Resin | 4 | 4 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (73)
Most recent Scientific Pharmaceuticals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor | LBH | 2020-02-18 | 172 |
| K051952 | EUGENONE | EMA | 2005-09-07 | 51 |
| K041886 | PROVISO | EBG | 2004-08-04 | 23 |
| K013555 | SCI-PHARM POST SECURE | EMA | 2002-01-23 | 90 |
| K001446 | LIGHT-CURED ORTHODONTIC BAND CEMENT | DYH | 2000-07-21 | 74 |
| K993324 | CARBOCEM ZINC POLYCARBOXYLATE CEMENT | EMA | 1999-11-09 | 36 |
| K982915 | SCI-PHARM DFV VARNISH | LBH | 1999-02-12 | 177 |
| K983305 | SCI-PHARM DESENSITIZING VARNISH | LBH | 1998-12-17 | 87 |
| K982913 | ZINFOS ZINC PHOSPHATE CEMENT | EMA | 1998-10-19 | 61 |
| K944466 | SEALDENT | EBI | 1995-03-02 | 176 |
63 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Scientific Pharmaceuticals, Inc..
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.
- Scientific Device Laboratory, Inc. (28 510(k)s)
- Scientific Sales Intl., Inc. (11 510(k)s)
- Scientific Distributors, Inc. (7 510(k)s)
- Scientific Device Manufacturer, LLC (6 510(k)s)
- Scientific Research (5 510(k)s)
- Scientific Imaging, Inc. (3 510(k)s)
- Scientific Specialties, Inc. (3 510(k)s)
- Scientific & General Pty. , Ltd. (2 510(k)s)
- Scientific Manufacturing Industries (2 510(k)s)
- Scientific Spinal , Ltd. (2 510(k)s)
- Scientific Standards, Inc. (2 510(k)s)
- Scientific Technology , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scientific Pharmaceuticals, Inc.?
FDA lists 73 510(k) clearances under the applicant name “Scientific Pharmaceuticals, Inc.” (first 1979, latest 2020), across 11 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 Scientific Pharmaceuticals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scientific Pharmaceuticals, Inc. is 61 days.
Which FDA product codes appear under Scientific Pharmaceuticals, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 29); EMA (Cement, Dental, 9); LBH (Varnish, Cavity, 9).
Next steps
- See all 73 Scientific Pharmaceuticals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Scientific Pharmaceuticals, Inc.'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.