Brea, CA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NXC | Aligner, Sequential | Class II | Dental | 3 | 2025-02-20 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Class II | Dental | 1 | 2025-01-03 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-02-20 | K250487 | SparkTM Clear Aligner System | NXC | Class II | Dental |
| 2025-01-03 | K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive | DYH | Class II | Dental |
| 2024-10-11 | K240501 | Spark Clear Aligner System | NXC | Class II | Dental |
| 2021-03-22 | K203737 | Spark Clear Aligner System | NXC | Class II | Dental |