Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank— 510(k) K260370
Substantially EquivalentBloomden Bioceramics (HuNan) Co., Ltd.
FDA 510(k) clearance K260370 for Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Substantially Equivalent on 2026-03-30. Applicant: Bloomden Bioceramics (HuNan) Co., Ltd.. Device class: 2.
Summary
Bloomden Bioceramics (HuNan) has two products in this record, Bloomden Dental Zirconia Blank and Dental Zirconia Pre-Shaded Blank. They're filed under EIH, porcelain powder. The record doesn't list sizes or shades.
Class II, 21 CFR 872.6660. It was a Traditional 510(k), and Dental is both the classification panel and the review panel.
Bloomden Bioceramics filed from Changsha, China. The decision came 53 calendar days after FDA received it (February 5 to March 30, 2026).
Clearance details
- Applicant
- Bloomden Bioceramics (HuNan) Co., Ltd.
- Product code
- Product code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changsha, CN
Recent devices under product code EIH
view allMore clearances from Bloomden Bioceramics (HuNan) Co., Ltd.
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