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510(k) K251084

zirkon; structure; LFU shades, stains and glazes by Estetic Ceram AG — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2025
Date Received
April 9, 2025
Clearance Type
Abbreviated
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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