The following data is part of a premarket notification filed by Kat Implants, Llc with the FDA for Kat Implants System One-piece Implants 2.5x10.
| Device ID | K112758 |
| 510k Number | K112758 |
| Device Name: | KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | KAT IMPLANTS, LLC 15 RYE STREET SUITE 115 Portsmouth, NH 03801 |
| Contact | Vitali Bondar |
| Correspondent | Vitali Bondar KAT IMPLANTS, LLC 15 RYE STREET SUITE 115 Portsmouth, NH 03801 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-22 |
| Decision Date | 2012-02-23 |
| Summary: | summary |