Kay See Dental Mfg. Co.: FDA clearances and approvals
Kay See Dental Mfg. Co. has 5 FDA 510(k) clearances (first 1999, latest 2000), across 5 product codes in 1 review panel. Median 510(k) review time: 37 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (5)
Most recent Kay See Dental Mfg. Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001309 | HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 | EBG | 2000-06-13 | 49 |
| K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | EBI | 1999-09-22 | 49 |
| K991161 | HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 | EIA | 1999-04-29 | 22 |
| K990306 | HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 | EBC | 1999-03-03 | 30 |
| K990155 | HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 | EMA | 1999-02-25 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Kay See Dental Mfg. 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 Kay See Dental Mfg. Co. have?
Kay See Dental Mfg. Co. has 5 FDA 510(k) clearances (first 1999, latest 2000), across 5 product codes in 1 review panel.
How long does FDA take to clear Kay See Dental Mfg. Co.'s 510(k)s?
The median time from FDA receipt to decision across Kay See Dental Mfg. Co.'s cleared 510(k)s is 37 days.
What devices does Kay See Dental Mfg. Co. make?
Its most frequent FDA product codes are EBC (Sealant, Pit And Fissure, And Conditioner, 1); EBG (Crown And Bridge, Temporary, Resin, 1); EBI (Resin, Denture, Relining, Repairing, Rebasing, 1).
Has Kay See Dental Mfg. Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kay See Dental Mfg. Co. Related entities may recall under other names.
Next steps
- See all 5 Kay See Dental Mfg. Co. clearances with predicates and recalls
- Run predicate analysis for product code EBC, Kay See Dental Mfg. 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.