510(k) K192530
K192530 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Surefil one Self-adhesive Composite Hybrid". The FDA issued a decision of Substantially Equivalent on Jan 23, 2020. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Dentsply Sirona has 87 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 23, 2020
- Date Received
- Sep 16, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type
- 510(k)