The following data is part of a premarket notification filed by Paltop Advanced Dental Solutions, Ltd with the FDA for Paltop Conical Implant System.
| Device ID | K220200 |
| 510k Number | K220200 |
| Device Name: | Paltop Conical Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Paltop Advanced Dental Solutions, Ltd Hashita 5, Industrial Park Caesarea, IL 3088900 |
| Contact | Zina Gurgov |
| Correspondent | Chris Brown Aclivi, LLC 3250 Brackley Drive Ann Arbor, MI 48105 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-05-25 |