FDA device listing
Cortical drill,Diamond Lindermann drill,Pilot drill,Sidecut drill,Step drill,Straight drill,Twist drill
FDA device listing 1955652753 · ACH Medical Co., Ltd.
Key facts
| Proprietary names | Cortical drill,Diamond Lindermann drill,Pilot drill,Sidecut drill,Step drill,Straight drill,Twist drill |
|---|---|
| Owner/operator | ACH Medical Co., Ltd. |
| Owner/operator number | 10043821 |
| Product codes | DZA |
| Device names | DZA - Drill, Dental, Intraoral |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4130 |
| Review panels | Dental |
| Registered establishments | ACH Medical Co., Ltd. |
| Establishment registrations | 3009848796 |
| FEI numbers | 3009848796 |
| Establishment operations | Manufacturer |
| 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