FDA 510(k) clearance · back to tracker
Dental Zirconia Blank & Coloring Liquid
Hunan Qinghao Puzhong Technology Co., Ltd. cleared K261046 on 2026-07-17, decision: substantially equivalent
K-number
K261046
Sponsor
Hunan Qinghao Puzhong Technology Co., Ltd.
Device
Dental Zirconia Blank & Coloring Liquid
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-07-17
Product code
EIH
Advisory committee
Dental
Medical specialty
Dental
Regulation number
872.6660
Official FDA record
Open K261046on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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