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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290114693769 | K220200 | 000 |
| 07290114693905 | K220200 | 000 |
| 07290114693912 | K220200 | 000 |
| 07290114693929 | K220200 | 000 |
| 07290114693936 | K220200 | 000 |
| 07290114693943 | K220200 | 000 |
| 07290114693950 | K220200 | 000 |
| 07290114693967 | K220200 | 000 |
| 07290114690096 | K220200 | 000 |
| 07290114693899 | K220200 | 000 |
| 07290114693882 | K220200 | 000 |
| 07290114693875 | K220200 | 000 |
| 07290114693776 | K220200 | 000 |
| 07290114693783 | K220200 | 000 |
| 07290114693790 | K220200 | 000 |
| 07290114693813 | K220200 | 000 |
| 07290114693820 | K220200 | 000 |
| 07290114693837 | K220200 | 000 |
| 07290114693844 | K220200 | 000 |
| 07290114693851 | K220200 | 000 |
| 07290114690980 | K220200 | 000 |
| 07290114690997 | K220200 | 000 |
| 07290114691000 | K220200 | 000 |
| 07290114691376 | K220200 | 000 |
| 07290114691383 | K220200 | 000 |
| 07290114691390 | K220200 | 000 |
| 07290114691406 | K220200 | 000 |
| 07290114691413 | K220200 | 000 |
| 07290114691420 | K220200 | 000 |
| 07290114691437 | K220200 | 000 |
| 07290114691444 | K220200 | 000 |
| 07290114691369 | K220200 | 000 |
| 07290114691345 | K220200 | 000 |
| 07290114691338 | K220200 | 000 |
| 07290114691017 | K220200 | 000 |
| 07290114691253 | K220200 | 000 |
| 07290114691260 | K220200 | 000 |
| 07290114691277 | K220200 | 000 |
| 07290114691284 | K220200 | 000 |
| 07290114691307 | K220200 | 000 |
| 07290114691314 | K220200 | 000 |
| 07290114691321 | K220200 | 000 |
| 07290114691451 | K220200 | 000 |