FDA device listing
Celtra Ceram,CELTRA Duo,Dentsply Sirona Universal Body Stain,Dentsply Sirona Universal Incisal Stain,Dentsply Sirona…
FDA device listing 1343158698 · DENTSPLY SIRONA INC
Key facts
| Proprietary names | Celtra Ceram,CELTRA Duo,Dentsply Sirona Universal Body Stain,Dentsply Sirona Universal Incisal Stain,Dentsply Sirona Universal Overglaze,Dentsply Sirona Universal Overglaze-High Flu,Dentsply Sirona Universal Stain,Dentsply Sirona Universal Stain & Overglaze Kit,Universal Body Stain,Universal Incisal Stain,Universal Overglaze,Universal Overglaze-High Flu,Universal Stain |
|---|---|
| Owner/operator | DENTSPLY SIRONA INC |
| Owner/operator number | 2511302 |
| Premarket submissions | K161269 |
| Product codes | EIH |
| Device names | EIH - Powder, Porcelain |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.6660 |
| Review panels | Dental |
| Registered establishments | DEGUDENT GMBH, DENTSPLY IH BV, DENTSPLY LLC, DS REP B.V. |
| Establishment registrations | 2424472, 2647456, 9681199, 3011824442 |
| FEI numbers | 2647456, 3002088145, 3003999430, 3011824442 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer, Specification Developer |
| 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