FDA device listing
Nova Aqua GIL, Nova Aqua GIF,Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L…
FDA device listing 1985733342 · IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.
Key facts
| Proprietary names | Nova Aqua GIL, Nova Aqua GIF,Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus, Nova Glass GL),Nova Glass II F, Nova Glass II LC, Fissured II Nova |
|---|---|
| Owner/operator | IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. |
| Owner/operator number | 10062241 |
| Premarket submissions | K210473 |
| Product codes | EMA |
| Device names | EMA - Cement, Dental |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3275 |
| Review panels | Dental |
| Registered establishments | IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. |
| Establishment registrations | 3005176727 |
| FEI numbers | 3005176727 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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