Whip Mix Corporation: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Whip Mix Corporation” (first 2014, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 159 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 |
|---|---|---|
| 2014 | 3 | 97 |
| 2015 | 0 | — |
| 2016 | 1 | 258 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 169 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 277 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Whip Mix Corporation took a median 223 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 2 | 2 |
| MQC | Mouthguard, Prescription | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
Review panels
- Dental (6)
Most recent Whip Mix Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241729 | Hard Splint & Thermo-Adaptive Splint | MQC | 2025-03-18 | 277 |
| K190107 | VeriSplint | MQC | 2019-07-10 | 169 |
| K152443 | Vericore Gradient Temporary Disc | EBG | 2016-05-11 | 258 |
| K142670 | Vericore Zirconia Blanks | EIH | 2014-10-22 | 33 |
| K140877 | VERICORE ZIRCONIA BLANKS | EIH | 2014-09-03 | 149 |
| K140146 | COMFORTSOFT SOFT DENTURE LINER SYSTEM | EBI | 2014-04-29 | 97 |
Recalls
openFDA lists no recalls under a recalling firm named Whip Mix Corporation.
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 Whip Mix Corporation?
FDA lists 6 510(k) clearances under the applicant name “Whip Mix Corporation” (first 2014, latest 2025), 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 Whip Mix Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Whip Mix Corporation is 159 days.
Which FDA product codes appear under Whip Mix Corporation?
The most frequent FDA product codes under this applicant name are EIH (Powder, Porcelain, 2); MQC (Mouthguard, Prescription, 2); EBG (Crown And Bridge, Temporary, Resin, 1).
Next steps
- See all 6 Whip Mix Corporation clearances with predicates and recalls
- Run predicate analysis for product code EIH, Whip Mix Corporation'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.