510(k) K240912
K240912 is an FDA 510(k) premarket notification submitted by Anhui Miisen Intelligence Technology Co., Ltd. for the device "Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)". The FDA issued a decision of Substantially Equivalent on May 31, 2024. 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
- May 31, 2024
- Date Received
- April 3, 2024
- 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