510(k) K250811
K250811 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 April 11, 2025. 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
- April 11, 2025
- Date Received
- March 17, 2025
- Clearance Type
- Special
- 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