K Number
K242400
Date Cleared
2024-10-10

(58 days)

Product Code
Regulation Number
872.6660
Panel
DE
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Dental porcelain powder is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.

Device Description

Dental porcelain powder is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure. Dental porcelain powder is composed of silicon oxide, aluminum oxide, boron oxide, potassium oxide, sodium oxide, magnesium oxide, calcium oxide, yttrium oxide, zirconium oxide, zinc oxide, strontium oxide, barium oxide, titanium oxide, titanium oxide, cerium oxide, vanadium oxide, bait oxide, praseodymium oxide, and other oxides, distilled water, 1,3-butylene glycol, 1,5-pentanediol, propanetriol, diethanolamine.

The product models are categorized into pastes (PAS), powders (POW) and liquids (LIQ) depending on the form of the product. Among them, pastes are made of powders and liquids.

The products are divided into different sizes according to the capacity of the different models.

The products are divided into different shades according to the different shades of the models of pastes (PAS) and powders (POW), and into different shades according to the strength of volatility of the products of the model of liquids (LIQ).

Dental porcelain powder is used for dental restorations, such as crown, bridge, inlay, veneer, using CAD/CAM or manual milling machines. The main ingredients of the product include zirconia, yttrium oxide, hafnium oxide, alumina and other oxides. Through the digital scanning of the tooth or tooth mold, the three-dimensional data of the tooth mold is obtained. According to the data, the CAD design is carried out to design the porcelain block processing model. Then CNC machine tool was used to make CAM according to the porcelain block processing model, and the inner crown of all-porcelain denture was made by air sintering or vacuum sintering, so as to achieve the strength and aesthetic effect required by clinical use. Finally, the inner crown of the all-porcelain denture was glazed with porcelain powder to form the combination of porcelain, and the all-porcelain denture was made.

AI/ML Overview

The provided text is a 510(k) Summary for a Dental porcelain powder (K242400). It describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device.

However, the document does not describe a study involving an AI/Machine Learning (ML) device or software. Instead, it focuses on the physical and chemical properties of a dental material. Therefore, most of the requested information regarding acceptance criteria and studies for AI/ML performance metrics (like sensitivity, specificity, MRMC studies, standalone performance, ground truth establishment, training set details) is not applicable to this submission.

The document states:

  • "10. Clinical Performance Data: Not applicable. Clinical performance testing has not been performed for the subject device."
  • "9. Summary of Non-Clinical Testing: Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the new device, Dental porcelain powders met its specifications."

Based on the information provided for this non-AI/ML medical device:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Set by Standard ISO 6872:2015)Reported Device Performance (Dental porcelain powder)
UniformityMeets acceptable criteria
Freedom from extraneous materialsMeets acceptable criteria
Mixing and compaction performanceMeets acceptable criteria
Flexural strengthMeets acceptable criteria
Chemical solubilityMeets acceptable criteria
RadioactivityMeets acceptable criteria
Coefficient of thermal expansionMeets acceptable criteria
Glass transition temperatureMeets acceptable criteria
Biocompatibility (Cytotoxicity)Meets acceptable criteria (per ISO 10993 standards)
Biocompatibility (Sensitization)Meets acceptable criteria (per ISO 10993 standards)
Biocompatibility (Irritation)Meets acceptable criteria (per ISO 10993 standards)
Biocompatibility (Systemic Toxicity)Meets acceptable criteria (per ISO 10993 standards)
Biocompatibility (Subchronic Toxicity)Meets acceptable criteria (per ISO 10993 standards)
Biocompatibility (Genotoxicity)Meets acceptable criteria (per ISO 10993 standards)
CompositionComparable to predicate (SiO2, Al2O3, K2O, Na2O, Li2O, color additives; liquid: deionized water, organic solvents)
FormPast, liquid, and powder
Type, class of dental ceramicType I – Class I
Single useYes
Available ColorVarious
SterileNon-sterile

2. Sample sized used for the test set and the data provenance:

  • The document does not specify the sample size used for the bench tests. It only states that tests were performed "per ISO 6872:2015 and internal procedures."
  • Data provenance is not explicitly stated but implies laboratory testing data. It is not clinical data, nor does it specify country of origin for the test data itself (though the applicant is from China). The tests are non-clinical (bench).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable. This is a material science study, not an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is defined by the objective physical and chemical standards of ISO 6872:2015.

4. Adjudication method for the test set:

  • Not applicable. Testing involves objective measurements against established standards, not subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

  • For the physical and chemical properties, the ground truth is established by the specifications and testing methodologies outlined in ISO 6872:2015 (Dentistry - Ceramic materials) and the manufacturer's internal final inspection criteria.
  • For biocompatibility, the ground truth is established by the ISO 10993 standards.

8. The sample size for the training set:

  • Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context. Material formulation and process development would involve iterative testing, but this is developmental, not part of a formal AI/ML training dataset.

9. How the ground truth for the training set was established:

  • Not applicable. As this is not an AI/ML device, there's no "training set" in the sense of labeled data for an algorithm. The development of the dental porcelain powder would follow material science principles and engineering specifications, where "ground truth" for material properties is derived from established scientific understanding and testing standards.

§ 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.