Data / Medical devices / United States / Surgikor, LLC
Surgikor, LLC: FDA-registered device maker in Los Angeles, CA, United States, 2 510(k) clearances
Surgikor, LLC is registered with the FDA (registration 3013173272) in Los Angeles, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 8, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013173272
- Address
- 1299 W. Jefferson Blvd, Los Angeles, CA, United States, 90007
- Owner or operator
- Surgikor, LLC (10053398)
- Roles
- Specification developer
- First device listed
- December 1, 2016
- Registered through
- 2026
- Brand names listed
- 15 Angled Anatomic Abutments with Shoulder, 15 Angular Abutment, 25 Angled Anatomic Abutments with Shoulder, 25 Angular Abutment, 30 Angled Anatomic Abutments with Shoulder, ADS R172 15 Abutment Driver hand and ratchet with Swivel L 15mm, ADS S172 10 Short Abutment Driver hand and rachet with swivel L 10mm, AN MAA and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Specification developer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 8, 2019 | K182615 | Surgikor Dental Implant System | DZE | Substantially Equivalent | Surgikor, LLC | accessdata.fda.gov |
| February 11, 2016 | K152555 | Dental Implant System | DZE | Substantially Equivalent | Ariabio International, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Drill, Dental, Intraoral
Updated July 8, 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.