The following data is part of a premarket notification filed by Kat Implants, Llc with the FDA for Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model: 002061, 002062, 002063, 002064,.
| Device ID | K101201 |
| 510k Number | K101201 |
| Device Name: | STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, |
| 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 | 2010-04-29 |
| Decision Date | 2011-04-13 |
| Summary: | summary |