510(k) K211916
K211916 is an FDA 510(k) premarket notification submitted by Ivoclar Vivadent, AG for the device "IPS e.max One". The FDA issued a decision of Substantially Equivalent on August 20, 2021. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Ivoclar Vivadent, AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 2021
- Date Received
- June 21, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type