The OPC 3G All-Ceramic System, Core and Overlay Porcelains are intended for either hot pressing or CAD/CAM machining all-ceramic dental restorations. The OPC 3G All-Ceramic System, Core and Overlay Porcelains should be used with 3G All-Ceramic materials only and not intermixed with other manufacturers products/porcelains. The system is used for fabrication of dental restorations including inlays, onlays, veneers, single units, and anterior SUSE Underges up to the first premolar ...

Device Description

The OPC 3G All-Ceramic System, Core and Overlay Porcelains comprise a lithium disilicate glassceramic core used for all-ceramic dental restorations. Subsequent layers of porcelain are applied over top to provide additional aesthetics and charactcrizations. This system offers high strength, low wear, the aesthetics of a metal-free system, and better thermal shock properties due to the lower thermal expansion of the materials used.

The dental restoration is prepared by a lost wax technique. The dental restorations are designed in a wax pattern and invested into refractory. The refractory is burned out to remove the wax and leave a cavity of the dental design. Pellets of 3G All-Ceramic are placed into the investment cavity and transferred to a hot pressing furnace where the investment/pellets are brought to a higher temperature. The temperature is maintained long enough for the glass-ceramic to become molten and then pressed into the cavity creating an exact duplicate of the original wax pattern.

In addition, dental restorations can be made by forming the material into pre made blocks of ceramics, which are milled to the coping/bridge shape by CAD/CAM cquipment.

The OPC 3G All-Ceramic System, Core and Overlay Porcelains will include Corc pcllcts, Corc Stains, Bodies, Incisals, Glazes, Investment, Investment Liquids, Acid Solutions (Shipped Separately), Acid Neutrilizers, Glaze Liquids, Disposable Plungers, Paper Rings, Plastic Scoops, MSDS and Instructions.

AI/ML Overview

The provided text is a 510(k) summary for the Jeneric/Pentron OPC 3G All-Ceramic System. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a formalized study with a test set, ground truth, and expert adjudication.

Therefore, the requested information cannot be fully extracted as such a study is not described.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided 510(k) summary. The document does not describe specific acceptance criteria (e.g., minimum strength, maximum wear) or present a table of the device's measured performance against such criteria. Instead, it relies on the similarity of composition and function to predicate devices to establish substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not applicable/not provided. The document does not describe a performance study with a distinct "test set" in the context of clinical or in vitro performance evaluation against acceptance criteria. There's no mention of a sample size or data provenance for such a test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This information is not applicable/not provided. As no specific performance study with a test set and ground truth is described, there's no mention of experts involved in establishing ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. Without a described performance study and ground truth establishment, there's no adjudication method mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

This information is not applicable/not provided. MRMC studies are typically done for diagnostic devices where human readers interpret images or data. The OPC 3G All-Ceramic System is a dental material, not a diagnostic device, and thus an MRMC study is not relevant or described.

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

This information is not applicable/not provided. The device is a dental material, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used:

This information is not applicable/not provided. Since no performance study against acceptance criteria is explicitly detailed, the type of ground truth used is not mentioned. The approval is based on "substantial equivalence" to predicate devices, implying that the established performance and safety of the predicate devices serve as the "ground truth" for comparison.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. As the submission is for a dental material based on substantial equivalence, there is no "training set" in the context of machine learning or AI algorithm development described.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable/not provided. As there is no training set described, the method for establishing its ground truth is also not mentioned.

Summary of the 510(k) Submission's Approach:

The Jeneric/Pentron 510(k) submission for the OPC 3G All-Ceramic System relies entirely on the concept of substantial equivalence to predicate devices (Finesse All-Ceramic Core, K971869, and Empress2 Core, K982616, and their corresponding overlay porcelains).

The core argument for equivalence is:

Similar Composition: The compositions for 3G All-Ceramic Core are similar to the predicate devices.
Similar Function: The device functions similarly to the predicate devices.
Intended Use: The intended use (all-ceramic dental restorations including inlays, onlays, veneers, single units, and anterior bridges) is consistent with devices already on the market.
Performance Characteristics: The description highlights desired characteristics like "high strength, low wear, the aesthetics of a metal-free system, and better thermal shock properties due to the lower thermal expansion." However, these are presented as inherent properties and benefits, not as measured results against specific acceptance criteria for a new clinical study.

The FDA's letter explicitly states that the device is deemed "substantially equivalent... to 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." This means a formal clinical trial or a performance study with defined acceptance criteria and expert adjudication against a ground truth dataset, as described in your prompt, was not the primary method used for this specific 510(k) clearance.

Summary

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K994435

21.0 510(K) SUMMARY

Submitter: Jeneric/Pentron, Inc. Address: 53 North Plains Industrial Road Wallingford. Connecticut 06492 Contact Tel: 203-265-7397 X619 Contact Fax: 203-265-7662 Contact Person: Annmarie Tenero

Date Summary Prepared: May 26, 2000

The compositions for 3G All-Ceramic Core is similar to Finesse All-Ceramic Core, K971869, Dentsply International and Empress2 Core, K982616, Ivoclar North America, in both composition and function. I.ikewise, the 3G All Ceramic overlay used in conjunction with the 3G Core is also similar to the overlay porcclains for these same cores, Finesse Porcelain and Empress2 Porcclain. Because of these similarities to predicate devices, the material is substantially equivalent.

In addition, dental restorations can be made by forming the material into pre made blocks of ceramics, which are milled to the coping/bridge shape by CAD/CAM cquipment.

The OPC 3G All-Ceramic System is intended for either hot pressing or CAD/CAM machining allceramic dental restorations. The 3G All-Ceramic System should be used with 3G All-Ceramic materials only and not intermixed with other manufacturers products/porcelains. The system is used for fabrication of dental restorations inlays, onlays, veneers, single units, and anterior bridges up to the first premolar.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2000

Ms. Annmarie Tenero Jeneric®/Pentron® Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724

K994435 Re : Trade Name: OPC 3G All-Ceramic System, Core and Overlay Porcelains Regulatory Class : II Product Code: EIH Dated: December 28, 1999 Received: December 30, 1999

Dear Ms. Tenero:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any

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Page 2 - Ms. Tenero

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

K. Walter

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5.0 INDICATION FOR USE STATEMENT

510(k) NUMBER (IF KNOWN): K994435

DEVICE NAME: OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS.

INDICATION FOR USE:

The OPC 3G All-Ceramic System, Core and Overlay Porcelains comprise a lithium disilicate glass-ceramic core used for all-ceramic dental restorations. Subsequent layers of porcelain are applied over top to provide additional aesthetics and characterizations. This system offers high strength, low wear, the aesthetics of a metal-free system, and better thermal shock properties due to the lower thermal expansion of the materials used.

The dental restoration is prepared by a lost wax technique. The dental restorations are designed in a wax pattern and invested into refractory. The refractory is burned out to remove the wax and leave a cavity of the dental design. Pellets of 3G All-Ceramic are placed into the investment cavity and transferred to a hot pressing furnace where the investment/pellets are brought to a higher temperature. The temperature is maintained long enough for the glassceramic to become molten and then pressed into the cavity creating an exact duplicate of the original wax pattern.

In addition, dental restorations can be made by forming the material into pre made blocks of ceramics, which are milled to the coping/bridge shape by CAD/CAM equipment.

(Division Sian-Off) Division of Dental, Infection Control, Division of Dental, Infection Control.
and General Hospital Devices പ്രശ്ചാര്യം പ്രവ്യാപ്പ്യൂട്ട്
510(k) Number ______________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over -The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

5.0

Jeneric/Pentron, Inc.

510K Submission - OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS

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.