FDA device listing
ParaCem Universal DC
FDA device listing 1143043832 · Coltene/Whaledent AG
Key facts
| Proprietary names | ParaCem Universal DC |
|---|---|
| Owner/operator | Coltene/Whaledent AG |
| Owner/operator number | 9089944 |
| Premarket submissions | K053040 |
| Product codes | EMA, KLE |
| Device names | EMA - Cement, Dental, KLE - Agent, Tooth Bonding, Resin |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3200, 872.3275 |
| Review panels | Dental |
| Registered establishments | COLTENE/WHALEDENT AG |
| Establishment registrations | 9613375 |
| FEI numbers | 3002806620 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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