Data / Medical devices / United States / Zuga Medical, Inc.
Zuga Medical, Inc.: FDA-registered device maker in Cleveland, OH, United States, 2 510(k) clearances
Zuga Medical, Inc. is registered with the FDA (registration 3010251542) in Cleveland, OH, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 30, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010251542
- Address
- 1163 E 40th St Ste 202, Cleveland, OH, United States, 44114
- Owner or operator
- Zuga Medical, Inc. (10044268)
- Roles
- Manufacturer
- First device listed
- May 20, 2013
- Registered through
- 2026
- Brand names listed
- Burs for Zuga Dental Implant Systems, Dental Drills for Zuga Dental Implant Systems, Zuga, Zuga Medical Dental Implant System
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 |
| Bur, Dental | EJL | 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 |
|---|---|---|---|---|---|---|
| June 30, 2018 | K171197 | Zuga Dental Implant System | DZE | Substantially Equivalent | Zuga Medical, Inc. | accessdata.fda.gov |
| April 30, 2013 | K122664 | ZUGA DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Zuga Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Dental, Intraoral
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Bur, Dental
- All makers of Accessories, Implant, Dental, Endosseous
Updated June 30, 2018. 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.