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 Standard	Reported Device Performance
ISO 6872:2008 for Dental Ceramics: Type II Class 1a&b and 2a	Classified 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 Strength	Metal-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 Solubility	Chemical solubility was tested. Reported results for chemical solubility are "substantially equivalent to the predicate devices." (As per ISO 6872:2008 requirements).
Flexural Strength	Flexural strength was tested. Reported results for flexural strength are "substantially equivalent to the predicate devices." (As per ISO 6872:2008 requirements).
Glass Transition Temperature	Glass 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.

Summary

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Synspar Advanced Pressable

Rev. 1

Contact:	Donna Marie Hartnett
Company:	Ardent, Inc. 175 Pineview Drive, Amherst, NY 14228(716) 691-0010
Date Prepared:	December 3, 2012
Trade Name:	Synspar Advance Pressable Ceramic (Pellets)
Classification Name:	Porcelain Powder for Clinical Use (872.6660)
Predicate Devices:	Prismatik NetPress (K050144)IPS InLine PoM System (K071848)

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

Intended Use:

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 g .
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)
The material is contraindicated for:
Pressing over metal frameworks beyond the CTE range I
Very deep sub-gingival preparations l
Patients with substantially reduced residual dentition 트
Patients with bruxism and .
트 Use on alloys with a silver (Ag) content of more than 14% and any alloys comprising copper (Cu) beyond trace quantities

Other limitations of use:

Combination with any other ceramic materials unless specified by 트 Instructions for Use
Pressing Synspar Advance Pressable Ceramic (Pellets) thinner ■ than 0.8mm
Layering of Synspar Advance Incisal and Body materials 트
· Pressing over metal frameworks that do not exhibit the required minimum thickness for copings or connectors.

FEB 2 0 2013

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510(K) SUMMARY

Synspar Advanced Pressable Ceramic

Rev. 1

Technological Characteristics: The Synspar Advance Pressable Ceramic (Pellets) represents a shade modification (pigment percentages) to the Prismatik NetPress (510k No. K050144) and can be used in the same "Press on Metal" technique as IPS InLine POM (K071848). Both Synspar Advance and Prismatic Netpress pellets represent modifications to the Synspar and Avante Porcelain Systems by Ardent Inc. Changes have been made in the device's formulation and processing technique.

Testing Summary: Synspar Advance Pressable Ceramic (Pellets) was tested according to ISO 6872:2008 and is classified as Type II Class 1a&b and 2a esthetic dental ceramic. Synspar Advanced Pressable Ceramic was also tested for Metal-Ceramic Bond Strength in accordance with ISO 9693:1999, A1:2005 Dentistry: Metal-ceramic dental restorative systems for its use in the Press on Metal technique. The device has been tested for flexural strength, chemical solubility, CTE, Metal-Ceramic Bond Strength, and Glass transition temperature and the results of such testing are substantially equivalent to the predicate devices.

All of the components have been used in legally marketed devices. The formulations have not been changed in ways that may adversely impact safety or efficacy.

We believe 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.

510K Summary 5-2

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 20, 2013

Ardent, Inc. C/O Donna Marie Hartnett, Esq. Director QA/Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, NY 14228

Re: K123613

Trade/Device Name: Synspar Advance Pressable Ceramic Pellets Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: November 20, 2012 Received: November 23, 2012

Dear Ms. Hartnett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/3/Picture/7 description: The image shows the name "Kwame O. Ulmer" in a stylized font. The letters are black and bold, and they are set against a white background. The letters "O" and "U" are stylized with geometric patterns. The name is likely a logo or a heading for a document.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Synspar Advance Pressable Ceramic Pellets

Indications For Use:

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

K123613

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)
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner
Page 1 of 1
Susan Runner, DDS, MA
2013.02.14 11:13:49
-05'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K123613
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Regulation Number and Section

§ 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.