FDA device listing
HANDY-MATE,ViVa 3 S 120V,Viva Mate,Viva Mate 3,Viva Mate 3U
FDA device listing 1273320236 · NAKANISHI INC.
Key facts
| Proprietary names | HANDY-MATE,ViVa 3 S 120V,Viva Mate,Viva Mate 3,Viva Mate 3U |
|---|---|
| Owner/operator | NAKANISHI INC. |
| Owner/operator number | 8030216 |
| Premarket submissions | K990646 |
| Product codes | EKX |
| Device names | EKX - Handpiece, Direct Drive, Ac-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | NAKANISHI INC., NSK AMERICA CORP. |
| Establishment registrations | 1422375, 9611253 |
| FEI numbers | 1000139790, 3002807687 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database