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510(k) K253191

DCMhotbond zircon by Dental Creativ Management GmbH — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2026
Date Received
September 26, 2025
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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