The following data is part of a premarket notification filed by Uniqa Dental Ltd with the FDA for Uniqa Dental Implants System.
| Device ID | K180598 |
| 510k Number | K180598 |
| Device Name: | UNIQA Dental Implants System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | UNIQA DENTAL LTD 26 Tom Lantos Blvd, Alon Center Netanya, IL 4276001 |
| Contact | Dima Goberman |
| 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 | 2018-03-07 |
| Decision Date | 2018-08-08 |
| Summary: | summary |