Pascal Co., Inc.: FDA clearances and approvals
Pascal Co., Inc. has 8 FDA 510(k) clearances (first 1991, latest 2010), across 5 product codes in 2 review panels. Median 510(k) review time: 80 days. openFDA lists 1 product recall by a recalling firm named Pascal Co., Inc.
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 |
|---|---|---|---|
| EFH | Paper, Articulation | 2 | 2 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 2 | 2 |
| LBH | Varnish, Cavity | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| MED | Sterilant, Medical Devices | 1 | 1 |
Review panels
- Dental (7)
- General Hospital (1)
Most recent Pascal Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102526 | BLO2X OXYGEN BLOCKER | EBF | 2010-10-22 | 50 |
| K090597 | FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH | LBH | 2009-03-16 | 11 |
| K040988 | ZIRCON-F PROPHYLAXIS PASTE | EJR | 2004-07-07 | 83 |
| K040661 | RADENT PROPHY PASTE | EJR | 2004-06-09 | 89 |
| K012889 | BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT | MED | 2003-05-27 | 637 |
| K030488 | FLUORILAQ | LBH | 2003-05-02 | 77 |
| K912632 | OCCLUDE | EFH | 1992-01-17 | 217 |
| K911259 | HYDENT | EFH | 1991-06-06 | 76 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-08-09.
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 Pascal Co., Inc. have?
Pascal Co., Inc. has 8 FDA 510(k) clearances (first 1991, latest 2010), across 5 product codes in 2 review panels.
How long does FDA take to clear Pascal Co., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pascal Co., Inc.'s cleared 510(k)s is 80 days.
What devices does Pascal Co., Inc. make?
Its most frequent FDA product codes are EFH (Paper, Articulation, 2); EJR (Agent, Polishing, Abrasive, Oral Cavity, 2); LBH (Varnish, Cavity, 2).
Has Pascal Co., Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Pascal Co., Inc; the most recent began 2005-08-09. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 8 Pascal Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFH, Pascal Co., Inc.'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.