The following data is part of a premarket notification filed by Vatech Co., Ltd. with the FDA for Dental Digital X-ray Imaging System.
| Device ID | K073365 |
| 510k Number | K073365 |
| Device Name: | DENTAL DIGITAL X-RAY IMAGING SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | VATECH CO., LTD. 30 NORTHPORT ROAD Sound Beach, NY 11789 |
| Contact | Stephen T Mlcoch |
| Correspondent | Stephen T Mlcoch VATECH CO., LTD. 30 NORTHPORT ROAD Sound Beach, NY 11789 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-30 |
| Decision Date | 2008-04-08 |
| Summary: | summary |