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510(k) Data Aggregation
(272 days)
Maxx Digm, Inc.
Zmaxx T Series is used in the manufacture of dental prosthetics.
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.
This document describes the Zmaxx T Series, a zirconia-based ceramic used in the manufacture of dental prosthetics. The submission is a 510(k) summary, aiming to establish substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Zmaxx T Series are based on conformity to international standards, primarily ISO 6872 for dental ceramics, and ISO 10993 for biocompatibility.
| Acceptance Criteria (Standard) | Reported Device Performance (Zmaxx T Series) | Predicate Device 1 (NATURAZ SERIES) Performance | Predicate Device 2 (BruxZir™ Anterior) Performance |
|---|---|---|---|
| ISO 6872 Requirements: | |||
| COE (Coefficient of Thermal Expansion) | $(10.6 \pm 0.5) \times 10^{-6} K^{-1}$ (meeting the ISO 6872 requirement) | $(11.5 \pm 0.5) \times 10^{-6} K^{-1}$ (meeting the ISO 6872 requirement) | $11 \times 10^{-6} K^{-1}$ (meeting the ISO 6872 requirement) |
| Flexural Strength | >600 MPa (meeting the ISO 6872 requirement) | >800 MPa (meeting the ISO 6872 requirement) | >650 MPa (meeting the ISO 6872 requirement) |
| Chemical Solubility |
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