510(k) K060365
K060365 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, Inc. for the device "APEXCAL". The FDA issued a decision of Substantially Equivalent on April 17, 2006. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Ivoclar Vivadent, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2006
- Date Received
- February 13, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Liner, Cavity, Calcium Hydroxide
- Device Class
- Class II
- Regulation Number
- 872.3250
- Review Panel
- DE
- Submission Type