510(k) K214005
K214005 is an FDA 510(k) premarket notification submitted by Shenzhen Yurucheng Dental Materials Co., Ltd. for the device "Zirconia Dental Ceramics". The FDA issued a decision of Substantially Equivalent on February 18, 2022. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Shenzhen Yurucheng Dental Materials Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2022
- Date Received
- December 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