Manufacturer registered with FDA
Zuga Medical, Inc.
Chagrin Falls, OH, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 7
- 510(k) clearances
- 22013–2018
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Zuga Medical, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Zuga Medical, Inc. | 2 clearances | 2013–2018 | Below |
| China | NMPA | Registration holder | 儒伽医疗科技有限公司ZUGA MEDICAL, INC. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Zuga Medical, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | ZugaZuga Medical Dental Implant System | 2013 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | ZugaZuga Medical Dental Implant System | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Dental Drills for Zuga Dental Implant Systems | 2015 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Burs for Zuga Dental Implant Systems | 2015 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Zuga | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ZUGA MEDICAL, INC.FDA reg. 3010251542 | Cleveland, OH, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044268). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.