FDA device listing
Audental 15; Audental 40+; Audental 30;Audental 35; Audental 43;Audental 02;Audental 54;Audental 61;,Audental…
FDA device listing 1447014984 · Qinhuangdao Audental Metal Technology Co., Ltd.
Key facts
| Proprietary names | Audental 15; Audental 40+; Audental 30;Audental 35; Audental 43;Audental 02;Audental 54;Audental 61;,Audental Pal;Audental Pal 2;Audental 60;Audental Pd80;Audental Pd80+;Audental Pd76;Audental Pd75;,Audental Pd49;Audental A10;Audental A20;Audental A35;Audental A25;Audental A25+;Audental U40;Audental 43+;,Audental Pd70;Audental Pd71;Audental Pd61;Audental Pd58;Audental Pd55;Audental Pd50;,Audental… |
|---|---|
| Owner/operator | Qinhuangdao Audental Metal Technology Co., Ltd. |
| Owner/operator number | 10054865 |
| Product codes | EJS |
| Device names | EJS - Alloy, Other Noble Metal |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3060 |
| Review panels | Dental |
| Registered establishments | Qinhuangdao Audental Metal Technology Co., Ltd. |
| Establishment registrations | 3013546336 |
| FEI numbers | 3013546336 |
| 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