Data / Medical devices / Hungary / S.G.S. International Ltd
S.G.S. International Ltd: FDA-registered device maker in Budapest, Hungary, 2 510(k) clearances
S.G.S. International Ltd is registered with the FDA (registration 3011545243) in Budapest, Hungary. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 29, 2019. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011545243
- Address
- Karolyi Istvan utca 1-3, Budapest, Hungary, H-1047
- Owner or operator
- S.G.S. International Ltd (10048289)
- Roles
- Manufacturer
- First device listed
- December 24, 2014
- Registered through
- 2026
- Brand names listed
- 17 Screw type Angular Abutment, Abutments Plastic for Casting with Titanium Base & Hex, Adaptor, Adaptor Key, Adaptor for driver, Analog, Anatomic Angular Abutment, Anatomic Angular Abutment for 7PN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 29, 2019 | K182219 | SGS Dental Implants System | DZE | Substantially Equivalent | Sgs International, Ltd. | accessdata.fda.gov |
| November 21, 2014 | K133362 | SGS DENTAL IMPLANT | DZE | Substantially Equivalent | Sgs International, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Drill, Dental, Intraoral
Updated August 29, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.