The following data is part of a premarket notification filed by Sgs International Ltd with the FDA for Sgs Dental Implants System.
| Device ID | K182219 |
| 510k Number | K182219 |
| Device Name: | SGS Dental Implants System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SGS International Ltd Karolyi Istvan Street 1-3 Budapest, HU H 1047 |
| Contact | Michaeli Shabtai |
| Correspondent | Daniela Levy Sterling Medical Registration 22815 Ventura Blvd Woodland Hills, CA 91364 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-15 |
| Decision Date | 2019-08-29 |