510(k) K261046
K261046 is an FDA 510(k) premarket notification submitted by Hunan Qinghao Puzhong Technology Co., Ltd. for the device "Dental Zirconia Blank & Coloring Liquid". The FDA issued a decision of Substantially Equivalent on July 17, 2026. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Hunan Qinghao Puzhong Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2026
- Date Received
- March 31, 2026
- 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