510(k) K223253
K223253 is an FDA 510(k) premarket notification submitted by Arum Dentistry Co., Ltd. for the device "Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)". The FDA issued a decision of Substantially Equivalent on February 27, 2023. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Arum Dentistry Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2023
- Date Received
- October 21, 2022
- 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