K Number
K123613
Device Name
SYNSPAR ADVANCED
Manufacturer
Date Cleared
2013-02-20

(89 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

Synspar Advance Pressable Ceramic (Pellets) is a leucite ceramic system for:

Press-on-Metal Restorations

  • Single unit fully anatomical crowns in the anterior and posterior regions
  • Fully anatomical splinted crowns and bridges in the anterior and posterior regions
  • Compatible with dental alloys in the CTE range 13.6-14.6 x 10°/K (25-500°C). Alloys should be copper-free and contain less than 14% silver.

Pressed All-ceramic Restorations

  • Adhesively cemented single unit anterior all-ceramic restorations (crowns, inlays, onlays, veneers)
Device Description

Synspar Advance Pressable Ceramic (Pellets) is a dental porcelain system composed of a leucite-ceramic which utilizes a press-on or conventional heat-pressing technique for dental restoration fabrication.

AI/ML Overview

Synspar Advanced Pressable Ceramic Pellets Study Summary

This document describes the acceptance criteria and the study that demonstrates the Synspar Advanced Pressable Ceramic Pellets meet these criteria. The device is a dental porcelain system designed for press-on-metal and pressed all-ceramic restorations.

1. Acceptance Criteria and Reported Device Performance

The Synspar Advance Pressable Ceramic (Pellets) was tested to demonstrate substantial equivalence to its predicate devices, Prismatik NetPress (K050144) and IPS InLine PoM System (K071848). The acceptance criteria are based on compliance with international standards for dental ceramics and metal-ceramic restorative systems, with the reported performance demonstrating substantial equivalence.

Acceptance Criterion StandardReported Device Performance
ISO 6872:2008 for Dental Ceramics: Type II Class 1a&b and 2aClassified as Type II Class 1a&b and 2a esthetic dental ceramic. This implies meeting the specified requirements for flexural strength, chemical solubility, and glass transition temperature for these types and classes of dental ceramics. Reported results are "substantially equivalent to the predicate devices" for these parameters.
ISO 9693:1999, A1:2005 Dentistry: Metal-ceramic dental restorative systems for Metal-Ceramic Bond StrengthMetal-Ceramic Bond Strength was tested in accordance with this standard. Reported results for Metal-Ceramic Bond Strength are "substantially equivalent to the predicate devices."
CTE (Coefficient of Thermal Expansion)CTE was tested. Reported results for CTE are "substantially equivalent to the predicate devices." (Note: The intended use specifies compatibility with dental alloys in the CTE range 13.6-14.6 x 10^-6/K (25-500°C), suggesting the device's CTE falls within or is compatible with this range).
Chemical SolubilityChemical solubility was tested. Reported results for chemical solubility are "substantially equivalent to the predicate devices." (As per ISO 6872:2008 requirements).
Flexural StrengthFlexural strength was tested. Reported results for flexural strength are "substantially equivalent to the predicate devices." (As per ISO 6872:2008 requirements).
Glass Transition TemperatureGlass transition temperature was tested. Reported results for glass transition temperature are "substantially equivalent to the predicate devices." (As per ISO 6872:2008 requirements).
Safety & Efficacy (overall)The overall conclusion is that the "prior use of the components in legally marketed devices, the similarity in the formulations between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of the Synspar Advance Pressable Ceramic (Pellets) for the intended use."

Note: The exact numerical values for the reported performance are not provided in the summary but are stated to be "substantially equivalent" to the predicate devices in accordance with the specified ISO standards.

2. Sample Size and Data Provenance (Test Set)

The document does not explicitly state the specific sample sizes used for each test (flexural strength, chemical solubility, CTE, metal-ceramic bond strength, glass transition temperature). However, it implies that the tests were conducted according to the methodologies outlined in ISO 6872:2008 and ISO 9693:1999, A1:2005, which typically specify minimum sample sizes for such evaluations.

Data Provenance: The studies were conducted by Ardent, Inc. (an American company) to support a 510(k) submission to the U.S. FDA. The data would therefore be considered retrospective in the context of device development and evaluation for marketing clearance. The country of origin of the data is implicitly the United States, given the company's location and the regulatory submission.

3. Number of Experts to Establish Ground Truth and Qualifications

This section is not applicable as the evaluation of this device is based on objective, quantifiable material property tests (e.g., flexural strength, bond strength, CTE) against established international standards, not on expert interpretation of clinical images or patient outcomes. Ground truth is derived from the direct measurement of physical and mechanical properties.

4. Adjudication Method (Test Set)

This section is not applicable for the same reasons as point 3. The assessment relies on direct measurements and adherence to specified performance metrics in international standards, not on expert adjudication of subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable. An MRMC study is typically performed for diagnostic devices where human readers interpret medical images or data. The Synspar Advanced Pressable Ceramic is a dental restorative material, and its performance is evaluated through material property testing, not through human reader interpretation.

6. Standalone (Algorithm Only) Performance

This section is not applicable. The device is a material, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not relevant.

7. Type of Ground Truth Used

The ground truth for the device's performance is established through objective material property testing against the requirements and methodologies outlined in recognized international standards:

  • ISO 6872:2008 Dental Ceramics: Establishes requirements for flexural strength, chemical solubility, and glass transition temperature.
  • ISO 9693:1999, A1:2005 Dentistry: Metal-ceramic dental restorative systems: Establishes requirements for metal-ceramic bond strength.

The device's performance values for these parameters are compared to those of the predicate devices and the required specifications within these standards.

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of evaluating a dental material's physical and mechanical properties. The device's formulation and processing underwent development and optimization, but this is a manufacturing/engineering process, not an AI training process. The listed tests are for verification/validation.

9. How Ground Truth for the Training Set Was Established

This section is not applicable, as there is no "training set" in the conventional sense for this type of device evaluation. The formulation and characteristics of the Synspar Advance Pressable Ceramic (Pellets) are developed and refined based on established dental materials science principles and manufacturing processes. The comparison to predicate devices and adherence to international standards serve as the benchmark for "ground truth" in determining substantial equivalence.

§ 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.