FDA device listing
Amalgam plugger DE Black Nr. 1,Amalgam plugger DE Black Nr. 2,Amalgam plugger Hollenback H1/2-3,Amalgam plugger serrated…
FDA device listing 1023416001 · COMMIC SURGICO
Key facts
| Proprietary names | Amalgam plugger DE Black Nr. 1,Amalgam plugger DE Black Nr. 2,Amalgam plugger Hollenback H1/2-3,Amalgam plugger serrated Nr. 0,Amalgam plugger serrated Nr. 1S,Amalgam plugger serrated Nr. 2S,Amalgam plugger smooth Nr. 1,Amalgam plugger smooth Nr. 2,Plugger, Machtou |
|---|---|
| Owner/operator | COMMIC SURGICO |
| Owner/operator number | 9057893 |
| Product codes | EKR |
| Device names | EKR - Plugger, Root Canal, Endodontic |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | COMMIC SURGICO |
| Establishment registrations | 3003956316 |
| FEI numbers | 3003956316 |
| 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