(135 days)
ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Dental Zirconia Blank is available in various specifications, which are combinations of height (1225mm), color model (0M1/A1 A3/B1B4/C1C4/D2~D4) and transparency model (T45).
This document describes the 510(k) premarket notification for ZMAXX Dental Zirconia Blanks (K191631). It does not pertain to an AI/ML powered medical device, therefore many of the requested categories (such as experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable.
Here's the information directly related to the acceptance criteria and study as presented:
Acceptance Criteria and Device Performance for ZMAXX Dental Zirconia Blanks (K191631)
This submission is for a medical device (ZMAXX Dental Zirconia Blanks) which is a physical material used for dental restorations, not an AI/ML software device. Therefore, the "acceptance criteria" and "device performance" are primarily based on meeting established industry standards for dental ceramic materials and demonstrating bio-compatibility, rather than performance metrics typically associated with AI/ML systems (e.g., accuracy, sensitivity, specificity).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with relevant ISO standards and a comparison to a predicate device.
| Characteristic / Test | Acceptance Criteria (Implicit from Standards/Predicate) | Reported Device Performance (ZMAXX Dental Zirconia Blanks) |
|---|---|---|
| Performance Test (per ISO 6872:2015) | Comply with ISO 6872:2015, Dentistry-Ceramic materials (e.g., strength requirements for Type II Class 5) | Comply with ISO 6872 (specifically, it is Type II Class 5) |
| Density Test | Comparable to predicate device (6.00 g/cm³) | 6.00 g/cm³ |
| Cytotoxicity (per ISO 7405:2008) | No adverse reaction identified | Tested; no adverse react identified |
| Intracutaneous Reactivity (per ISO 10993-10:2010) | No adverse reaction identified | Tested; no adverse react identified |
| Sensitization (per ISO 10993-10:2010) | No adverse reaction identified | Tested; no adverse react identified |
| Acute Systematic Toxicity (per ISO 10993-11:2006) | No adverse reaction identified | Tested; no adverse react identified |
| Genotoxicity (per ISO 10993-3:2014) | No adverse reaction identified | Tested; no adverse react identified |
| Chemical Composition (Weight %) | ZrO₂ >99.0%, Inorganic Pigment (Al₂O₃, SiO₂, Fe₂O₃, Er₂O₃) 99.0%, Inorganic Pigment (Al₂O₃, SiO₂, Fe₂O₃, Er₂O₃) |
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.