510(k) K180703
K180703 is an FDA 510(k) premarket notification submitted by Vita Zahnfabrik H.Rauter GmbH Co. for the device "VITA YZ ST and VITA YZ XT". The FDA issued a decision of Substantially Equivalent on Aug 1, 2018. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Vita Zahnfabrik H.Rauter GmbH Co. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 1, 2018
- Date Received
- Mar 19, 2018
- Clearance Type
- Abbreviated
- 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
- 510(k)