510(k) K153767
K153767 is an FDA 510(k) premarket notification submitted by Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. for the device "X-cera Zirconia Blanks". The FDA issued a decision of Substantially Equivalent on March 29, 2016. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2016
- Date Received
- December 30, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type