The following data is part of a premarket notification filed by Kat Implants, Llc with the FDA for Kat Implant System.
| Device ID | K083544 |
| 510k Number | K083544 |
| Device Name: | KAT IMPLANT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-28 |
| Decision Date | 2009-02-02 |
| Summary: | summary |