FDA device listing
Analog,Analog Screw,Anatomic Healing Abutment Case,Angle Guide Tool,AXA Carrier,AXA Driver,AXA Scanbody for R2…
FDA device listing 1552614089 · MEGAGEN IMPLANT CO. LTD
Key facts
| Proprietary names | Analog,Analog Screw,Anatomic Healing Abutment Case,Angle Guide Tool,AXA Carrier,AXA Driver,AXA Scanbody for R2 Phtogram,AXA Scanbody Kit for R2 Photogram,B.I.C Carrier,B.I.C Guide Pin,Bite Impression Cap,Bite Impression Coping,Bone Carrier,Bone Condenser,Bone Profiler,Bone Profiler & Bone Profiler Guide Pin,Bone Profiler Guide Pin Jig,Bone Splitter 1,Bone Splitter 2,Burn-Out Cylinder,Bur… |
|---|---|
| Owner/operator | MEGAGEN IMPLANT CO. LTD |
| Owner/operator number | 9067358 |
| Product codes | NDP |
| Device names | NDP - Accessories, Implant, Dental, Endosseous |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3980 |
| Review panels | Dental |
| Registered establishments | Megagen Implant Co., Ltd., MegaGen Implant Co., Ltd. (Research Laboratories) |
| Establishment registrations | 3005554774, 3030089802 |
| FEI numbers | 3005554774, 3030089802 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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