(86 days)
The Multi M Series is used in the manufacture of dental prosthesis.
Multi M Series is zirconia-based ceramic provided in various shapes such as round and it is used to manufacture cores of all ceramic crowns and is classified into ISO 6872 Type 2 Class 5. 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 278 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. Multi M Series offers various types as follows: W-type, Z-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. Users can choose a type which fits the jig they have.
This document is a 510(k) clearance letter for a medical device called "Multi M Series", which is a dental material. The standard 510(k) clearance process by the FDA does not typically include the kind of clinical study details usually associated with AI/ML-based diagnostic devices (e.g., sample size for test sets, expert consensus, MRMC studies, effect size of AI assistance). This device is a material, not a diagnostic algorithm.
Therefore, many of the requested points regarding acceptance criteria and study details (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of device and submission. The "study" here refers to non-clinical performance and biocompatibility testing against international standards.
However, I can extract the relevant information where it exists:
The device in question, "Multi M Series," is a dental material (zirconia-based ceramic) used to manufacture dental prosthetics, not an AI-powered diagnostic device. Therefore, the "acceptance criteria" and "study" described are based on non-clinical performance and biocompatibility testing against established international standards for dental materials, rather than clinical efficacy studies with human subjects or AI algorithm performance benchmarks.
Acceptance Criteria and Device Performance
The acceptance criteria are derived from ISO 6872 (for ceramic materials) and ISO 10993 (for biocompatibility).
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Standard/Requirement | Predicate Device (Zmaxx T Series) Performance | Subject Device (Multi M Series) Performance | Meets Acceptance Criteria? |
|---|---|---|---|---|
| Mechanical/Physical | ||||
| CTE | ISO 6872 | (10.6 ± 0.5) × 10⁻⁶ K⁻¹ | (10.6 ± 0.5) × 10⁻⁶ K⁻¹ | Yes |
| Flexural Strength | ISO 6872 | > 600 MPa | > 800 MPa | Yes (exceeds predicate) |
| Chemical Solubility | ISO 6872 |
§ 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.