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510(k) K260370

Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank by Bloomden Bioceramics (HuNan) Co., Ltd. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2026
Date Received
February 5, 2026
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

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