The following data is part of a premarket notification filed by Paltop Advanced Dental Solutions Ltd with the FDA for Paltop Narrow Implant, Paltop Short Implant.
| Device ID | K130462 |
| 510k Number | K130462 |
| Device Name: | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PALTOP ADVANCED DENTAL SOLUTIONS LTD 5 HASHITA STREET PO BOX 3568 Caesarea, IL Is |
| Contact | Tal Hammer-topaz |
| Correspondent | Tal Hammer-topaz PALTOP ADVANCED DENTAL SOLUTIONS LTD 5 HASHITA STREET PO BOX 3568 Caesarea, IL Is |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-22 |
| Decision Date | 2013-08-27 |
| Summary: | summary |