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510(k) Data Aggregation
K Number
K251084Device Name
zirkon; structure; LFU shades, stains and glazes
Manufacturer
estetic ceram ag
Date Cleared
2025-06-05
(57 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
estetic ceram ag
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Types of restorations:
1. Anterior and posterior crowns
2. Veneers, inlays, onlays.
Device Description
zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.
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