510(k) K242407
K242407 is an FDA 510(k) premarket notification submitted by Hunan Vsmile Biotechnology Co., Ltd. for the device "Dental Glass Ceramics Blocks (HT, LT, MT)". The FDA issued a decision of Substantially Equivalent on November 13, 2024. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Hunan Vsmile Biotechnology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2024
- Date Received
- August 14, 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