510(k) K230270
K230270 is an FDA 510(k) premarket notification submitted by 3M Espe Dental Products for the device "3M VitCal Liner/Base". The FDA issued a decision of Substantially Equivalent on February 6, 2023. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. 3M Espe Dental Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2023
- Date Received
- January 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Liner, Cavity, Calcium Hydroxide
- Device Class
- Class II
- Regulation Number
- 872.3250
- Review Panel
- DE
- Submission Type