Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K-Number: K260370 · 2026-03-30
Decision Date2026-03-30
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device manufactured by Bloomden Bioceramics (HuNan) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-30 under approval number K260370. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2026-03-30. It is manufactured by Bloomden Bioceramics (HuNan) Co., Ltd.. The 510(k) number is K260370.
When was Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank approved by the FDA?
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2026-03-30, under approval number K260370.
What company makes Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is manufactured by Bloomden Bioceramics (HuNan) Co., Ltd..
What is the FDA product code for Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?
The FDA product code for Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.
Related Clinical Trials
Other Devices by Bloomden Bioceramics (HuNan) Co., Ltd.
Related Devices (Code: EIH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.