510(k) K242400
K242400 is an FDA 510(k) premarket notification submitted by Yilink (Tianjin) Biotechnology Co., Ltd. for the device "Dental porcelain powder". The FDA issued a decision of Substantially Equivalent on October 10, 2024. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Yilink (Tianjin) Biotechnology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2024
- Date Received
- August 13, 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