FDA device listing
BioPure MTAD Root Canal Cleanser
FDA device listing 1196670537 · DENTSPLY SIRONA INC
Key facts
| Proprietary names | BioPure MTAD Root Canal Cleanser |
|---|---|
| Owner/operator | DENTSPLY SIRONA INC |
| Owner/operator number | 2511302 |
| Premarket submissions | K053167 |
| Product codes | KJJ |
| Device names | KJJ - Cleanser, Root Canal |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.KJJ |
| Review panels | Dental |
| Registered establishments | DENTSPLY LLC, TULSA DENTAL PRODUCTS LLC |
| Establishment registrations | 2320721, 2515379 |
| FEI numbers | 2515379, 1000554802 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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