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510(k) Data Aggregation
K Number
K082652Device Name
BITTAR ZIRCONIA BLOCKS
Manufacturer
Date Cleared
2008-12-30
(109 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
BITTAR ZIRCONIA BLOCK, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Bittar Zirconia Blocks are indicated for use as a substructure for ceramic dental restorations. All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
Device Description
Bittar Zirconia Blocks are an all ceramic core material made of high bisque fired Zirconia Oxide (ZrO2), and are provided in either block, rod or disk shape. CAD/CAM fabrication of the core material can then be used to produce copings and / or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2 The milling and final oven hardening process (i.e., sintering) is completed by the end user.
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