San Marcos, CA, US · 9 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EMA | Cement, Dental | Class II | Dental | 5 | 2025-12-09 |
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 2 | 2025-05-27 |
| EIH | Powder, Porcelain | Class II | Dental | 1 | 2022-03-18 |
| KLE | Agent, Tooth Bonding, Resin | Class II | Dental | 1 | 2022-03-18 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-09 | K252808 | GlasIonomer FX-LC | EMA | Class II | Dental |
| 2025-10-28 | K252165 | ZIRCONOMER P | EMA | Class II | Dental |
| 2025-07-11 | K251470 | ResiCem EX | EMA | Class II | Dental |
| 2025-05-27 | K251578 | BEAUTIFIL II | EBF | Class II | Dental |
| 2023-09-28 | K233161 | BeautiLink SA | EMA | Class II | Dental |
| 2022-09-22 | K222253 | GlasIonomer FX ULTRA | EMA | Class II | Dental |
| 2022-03-18 | K213965 | BeautiBond Xtreme | KLE | Class II | Dental |
| 2022-03-18 | K212939 | Vintage Prime Press | EIH | Class II | Dental |
| 2021-02-05 | K200470 | Shofu Block HC Hard | EBF | Class II | Dental |