510(k) K213570
K213570 is an FDA 510(k) premarket notification submitted by Aidite (Qinhuangdao) Technology Co., Ltd. for the device "Dental Zirconia Ceramic". The FDA issued a decision of Substantially Equivalent on January 7, 2022. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Aidite (Qinhuangdao) Technology Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2022
- Date Received
- November 10, 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