510(k) K232174
K232174 is an FDA 510(k) premarket notification submitted by Genoss Co., Ltd. for the device "rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono". The FDA issued a decision of Substantially Equivalent on February 23, 2024. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Genoss Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 2024
- Date Received
- July 21, 2023
- 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