The following data is part of a premarket notification filed by Aso International Manila, Inc. with the FDA for Asoaligner.
| Device ID | K201104 |
| 510k Number | K201104 |
| Device Name: | AsoAligner |
| Classification | Aligner, Sequential |
| Applicant | Aso International Manila, Inc. Atlantica Bldg. 5, Block 12, Phase 1, South Avenue, Cavite Economic Zone Cavite, PH 4106 |
| Contact | Hiromichi Takahashi |
| Correspondent | Giselle Zhang Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-24 |
| Decision Date | 2021-02-26 |