Racine, WI, US · 6 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KIF | — | — | — | 2 | 2024-08-28 |
| EMA | Cement, Dental | Class II | Dental | 1 | 2026-04-15 |
| LBH | Varnish, Cavity | Class II | Dental | 1 | 2025-01-08 |
| KJJ | Cleanser, Root Canal | Unclassified | Unknown | 1 | 2024-08-27 |
| NYL | — | — | — | 1 | 2021-12-02 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-05-27 | Class II | Ongoing | Z-2400-2026 | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28 | — | Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different fir… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-04-15 | K253337 | REGEN Bioactive Cement | EMA | Class II | Dental |
| 2025-01-08 | K241489 | ReminGel | LBH | Class II | Dental |
| 2024-08-28 | K241457 | Vista BC Putty | KIF | — | — |
| 2024-08-27 | K241354 | Sealer Solvent | KJJ | Unclassified | Unknown |
| 2022-11-21 | K221811 | Vista BC Sealer | KIF | — | — |
| 2021-12-02 | K211721 | PS System | NYL | — | — |