510(k) K211212
K211212 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "LoFric Elle". The FDA issued a decision of Substantially Equivalent on Feb 17, 2022. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Dentsply Sirona has 87 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 17, 2022
- Date Received
- Apr 23, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type
- 510(k)