The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Ton-95lh, Pax-i3d Ortho.
| Device ID | K132983 |
| 510k Number | K132983 |
| Device Name: | TON-95LH, PAX-I3D ORTHO |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | VATECH CO., LTD. 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Contact | Dave Kim |
| Correspondent | Dave Kim VATECH CO., LTD. 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-23 |
| Decision Date | 2014-08-07 |
| Summary: | summary |