OPC LOWWEAR PORCELAIN by JENERIC/PENTRON, INC.

OPC LowWear™ Porcelain (enamel and incisal for mixing) is to be used in conjunction with Optimal Pressable Ceramic (OPC) pellets for all-ceramic fixed prosthodontics, inckluding full crowns, veneers and inlays/onlays. These translucent porcelains are applied in thin layers over the OPC pellet pressed ceramic cores. The average crystal size of the leucite within the LowWear Porcelain glassy matrix is 2-3 µm, with a crystal size range between 1-4 µm. The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 um) results in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham.

Device Description

AI/ML Overview

This document is a 510(k) premarket notification letter for a dental device, specifically "OPC LowWear™ Porcelain." It primarily focuses on the regulatory approval and indications for use, rather than a detailed study report with specific acceptance criteria and performance data.

Therefore, much of the requested information regarding detailed acceptance criteria, study methodologies, statistical results, ground truth establishment, and training set information is not present in the provided text.

However, based on the available information, here's what can be extracted:

Acceptance Criteria and Study Details (Based on provided text):

The document does not explicitly present a table of acceptance criteria with corresponding device performance values. However, it mentions the basis for the device's claim regarding low wear.

Acceptance Criteria (Implied)	Reported Device Performance
Reduction in Abrasion against Opposing Dentition (This is the primary performance claim highlighted for "LowWear" porcelain, implicitly requiring a lower abrasive effect compared to predicate devices or conventional porcelains).	"The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 um) results in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham." (The document states the support, but does not provide the quantitative results or acceptance threshold from the "independent testing").
Material Characteristics (Related to the mechanism for low wear)	Average crystal size of leucite: 2-3 µm Crystal size range of leucite: 1-4 µm (This is stated as a characteristic, which presumably meets an internal specification for the "LowWear" claim, but no specific acceptance range for these values is given in relation to a performance metric).

Acceptance Criteria (Implied)

Reported Device Performance

Reduction in Abrasion against Opposing Dentition (This is the primary performance claim highlighted for "LowWear" porcelain, implicitly requiring a lower abrasive effect compared to predicate devices or conventional porcelains).

"The smaller leucite crystals vs. conventional porcelains and other all-ceramic porcelains (average 8 um, range 1-40 um) results in less abrasion against opposing dentition, as supported by independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham." (The document states the support, but does not provide the quantitative results or acceptance threshold from the "independent testing").

Material Characteristics (Related to the mechanism for low wear)

Average crystal size of leucite: 2-3 µm Crystal size range of leucite: 1-4 µm (This is stated as a characteristic, which presumably meets an internal specification for the "LowWear" claim, but no specific acceptance range for these values is given in relation to a performance metric).

Additional Information based on the text:

Sample size used for the test set and the data provenance: Not specified in the provided text. The document only references "independent testing from Dr. Shiro Suzuki, University of Alabama at Birmingham." without detailing the test set size or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The testing was done by "Dr. Shiro Suzuki, University of Alabama at Birmingham," implying one expert or a team led by Dr. Suzuki, but the number and qualifications are not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided text. It refers to "independent testing," which would typically follow a scientific methodology, but the adjudication process for results is not described.
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 device is a dental material (porcelain), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a dental material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" or evidence for the low-wear claim likely comes from experimental test data (e.g., in-vitro abrasion tests mimicking dental function or potentially in-vivo studies, although the document doesn't specify). This data was generated by "independent testing."
The sample size for the training set: Not applicable. This is a manufactured dental material, not a machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of missing information:

The provided 510(k) clearance letter is a regulatory document affirming substantial equivalence to a predicate device. It confirms the device's indications for use and acknowledges the supporting "independent testing" for the low-wear claim but does not provide the detailed scientific study report that would contain the quantitative acceptance criteria, methodology, specific performance data, sample sizes, and ground truth establishment details. To get that information, one would typically need access to the actual "independent testing" report referenced.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1998

Mr. Murray G. Gamberg Quality Systems Director Jeneric®/Pentron® Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724

Re : K982377 OPC Low wear™ Porcelain Trade Name: Requlatory Class: II Product Code: EIH Dated: June 24, 1998 Received: July 8, 1998

Dear Mr. Gamberg:

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 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). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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. ਚੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Gamberg

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 regulation (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"(21CFR 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/dsma/dsmamain.html" .......

Sincerely yours,

S. Dutman for

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

Enclosure ---------

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510(k) Number (if known):	K982377
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Device Name: OPC LowWear™ Porcelain

Indications for Use:

Sason Rusk

s (0(k) Number

and General Hospital Devices , circus of Dental, Infection Control, (HO-ugis noisi (1)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Over-the Counter Use

(Optional Format 1-2-96)

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.