| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EBI | — | — | — | 2 | 2025-11-21 |
| NXC | Aligner, Sequential | Class II | Dental | 2 | 2024-03-05 |
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 2 | 2023-11-01 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-21 | K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | EBI | — | — |
| 2024-03-05 | K240597 | TERA HARZ CLEAR | NXC | Class II | Dental |
| 2023-11-01 | K233502 | TERA HARZ II | EBF | Class II | Dental |
| 2022-11-03 | K223355 | Tera Harz Clear | NXC | Class II | Dental |
| 2022-08-11 | K222414 | TERA HARZ DENTURE | EBI | — | — |
| 2021-07-15 | K202846 | TERA HARZ | EBF | Class II | Dental |