510(k) K192535
K192535 is an FDA 510(k) premarket notification submitted by Qinhuangdao Audental Metal Technology Co., Ltd. for the device "Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia". The FDA issued a decision of Substantially Equivalent on Jan 31, 2020. 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
- Jan 31, 2020
- Date Received
- Sep 16, 2019
- 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
- 510(k)