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510(k) Data Aggregation
K Number
K161219Device Name
Zmaxx T Series
Manufacturer
Maxx Digm, Inc.
Date Cleared
2017-01-26
(272 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Maxx Digm, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zmaxx T Series is used in the manufacture of dental prosthetics.
Device Description
Zmaxx T Series is zirconia-based ceramic provided in various shapes such as round and square and it is used to manufacture cores of all ceramic crowns, and is classified into ISO 6872 Type 2 Class 4. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers three different shades to meet the needs of different patients tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine.
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