The following data is part of a premarket notification filed by Paltop Advanced Dental Solutions, Ltd with the FDA for Paltop Narrow Implant.
| Device ID | K210117 |
| 510k Number | K210117 |
| Device Name: | Paltop Narrow Implant |
| 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 | 2021-01-19 |
| Decision Date | 2021-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290114691482 | K210117 | 000 |
| 07290114690621 | K210117 | 000 |
| 07290114690614 | K210117 | 000 |
| 07290114690607 | K210117 | 000 |
| 07290114690591 | K210117 | 000 |
| 07290114690263 | K210117 | 000 |
| 07290114690102 | K210117 | 000 |
| 07290114694148 | K210117 | 000 |
| 07290114692205 | K210117 | 000 |
| 07290114690645 | K210117 | 000 |
| 07290114690652 | K210117 | 000 |
| 07290114690669 | K210117 | 000 |
| 07290114690935 | K210117 | 000 |
| 07290114690928 | K210117 | 000 |
| 07290114690911 | K210117 | 000 |
| 07290114690904 | K210117 | 000 |
| 07290114690706 | K210117 | 000 |
| 07290114690690 | K210117 | 000 |
| 07290114690683 | K210117 | 000 |
| 07290114690676 | K210117 | 000 |
| 07290114692199 | K210117 | 000 |