FDA device listing
Calcium Hydroxide Temporary Filling Material (KP-Cal)
FDA device listing 1850025962 · Guilin Kevin Peter Technology Co., Ltd.
Key facts
| Proprietary names | Calcium Hydroxide Temporary Filling Material (KP-Cal ) |
|---|---|
| Owner/operator | Guilin Kevin Peter Technology Co., Ltd. |
| Owner/operator number | 10085586 |
| Premarket submissions | K261514 |
| Product codes | EJK, KIF |
| Device names | EJK - Liner, Cavity, Calcium Hydroxide, KIF - Resin, Root Canal Filling |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3250, 872.3820 |
| Review panels | Dental |
| Registered establishments | GUILIN KEVIN PETER TECHNOLOGY CO., LTD. |
| Establishment registrations | 3023816720 |
| FEI numbers | 3023816720 |
| 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