48890 Milmont Dr. Suite 101D, Fremont, United States, 94538
Showing 1–20 of 23 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| AIRFLEX ALIGNERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| FXBRIGHT ALIGNERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| FXBRIGHT RETAINERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| FXCLEAR ALIGNERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| FXTETRA ALIGNER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| FXTETRA BRIGHT ALIGNERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| FXTETRA BRIGHT RETAINERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Nightwear Aligners | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| NITIME ALIGNER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| OrthoFX Bright Aligner | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ORTHOFX BRIGHT ALIGNERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| OrthoFX Bright Retainer | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ORTHOFX BRIGHT RETAINERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ORTHOFX CLEAR ALIGNER | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ORTHOFX CLEAR ALIGNER 2.0 | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ORTHOFX CLEAR ALIGNERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ORTHOFX CLEAR RETAINER | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| OrthoFX NiTime Aligner | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ORTHOFX RESCUE ALIGNER | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| PRECISION FINISH ALIGNERS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
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