510(k) K212765
K212765 is an FDA 510(k) premarket notification submitted by Bloomden Bioceramics (HuNan) Co., Ltd. for the device "Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank". The FDA issued a decision of Substantially Equivalent on November 15, 2021. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Bloomden Bioceramics (HuNan) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2021
- Date Received
- August 31, 2021
- 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