The GC Initial dental ceramic system is a feldspathic porcelain system based on partially crystalline but mostly vitreous materials derived from phyllosilicates such as potash or soda feldspar, several commercially available fluxes, and various refractive oxides for mechanical enhancement.

AI/ML Overview

This is a 510(k) premarket notification for a Dental Ceramic Material (GC Initial MC, GC Initial AL, GC Initial LF). Upon reviewing the provided text, there is no detailed information regarding acceptance criteria for device performance, nor a study proving the device meets said criteria.

The document primarily focuses on:

Identifying the device and its manufacturer.
Stating its intended use (fabricating dental restorations).
Mentioning its classification and product code.
Identifying legally marketed equivalent devices (predicates).
Asserting that it has "identical technological characteristics" to the predicate devices and "meets the appropriate ISO Standards."

Therefore, I cannot provide the requested information as it is not present in the provided 510(k) summary.

To elaborate on why this information is missing:

Acceptance Criteria and Reported Performance: The document states the device has "identical technological characteristics" to predicates and "meets the appropriate ISO Standards." However, it does not specify which ISO standards, nor does it present specific numerical acceptance criteria or performance data from a study.
Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set): The 510(k) summary is generally a high-level overview. Detailed study protocols, results, and specific methodologies for establishing ground truth, sample sizes for test and training sets, or expert qualifications are typically found in more comprehensive technical documentation submitted to the FDA, but not usually in the summary itself.
Comparative Effectiveness Study (MRMC) or Standalone Performance: While the document implies equivalence to predicate devices, it does not describe a formal comparative effectiveness study involving human readers with and without AI assistance, nor does it provide standalone performance metrics for the device. Given that this is a dental ceramic material, an "AI" component or "human readers" in the context of diagnostic interpretation is not applicable here; the device itself is a material, not a diagnostic algorithm.

In summary, the provided text does not contain the specific details about acceptance criteria or a comprehensive study that you've requested beyond stating adherence to unspecified ISO standards and equivalence to predicate devices.

Summary

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K040567

APR 2 2 2004

510(k) SUMMARY

Submitted by:	GC America Inc
Contact Person:	Terry L. Joritz
Date Prepared:	February 24, 2004
Proprietary Name:	GC Initial MC, GC Initial AL, GC Initial LF
Common Name:	Dental Ceramic Material
Device Classification Name:	Porcelain powder for dental use
Classification :	Class II medical device
Product Code :	EIH Regulation Number 872.6660
Legally marketed equiv. devices:	Willi Geller Creation& CC Porcelain 510(k) #K981490Willi Geller Creation& AV Porcelain 510(k) #K002041Willi Geller Creation& LF Porcelain 510(k) #K002904
Description of the Device:	The GC Initial dental ceramic system is a feldspathic porcelainsystem based on partially crystalline but mostly vitreous mate-rials derived from phyllosilicates such as potash or soda feld-spar, several commercially available fluxes, and various refrac-tive oxides for mechanical enhancement.
Intended Use of the Device:	The product is intended to be used by dental technicians tofabricate dental restorations including porcelain fused to metalor alumina based cores crowns and bridges, laminate veneers,and inlays.
Technological Characteristics	The GC Initial dental ceramic has identical technological cha-racteristics to the Willi Geller Creation& porcelain system andindicates therefore the same harmless environmental propertiesas the predicate device. It also meets the appropriate ISO Stan-dards

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Image /page/1/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three horizontal lines above the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2004

Ms. Terry L. Joritz Director, Regulatory Affairs and Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

Re: K040567

Trade/Device Name: GC Initial Dental Porcelain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 02, 2004 Received: March 17, 2004

Dear Ms. Joritz:

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.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 – Ms. Terry L. Joritz

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 127 b lobalitos on that your device complies with other requirements mean that FDA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal statues and regisements, including, but not limited to: registration You must comply with an the Hec broq.21 CFR Part 801); good manufacturing practice alla listing (21 CT K Part 007), laoelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality sions ontrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This iction will anow you to begal finding of substantial equivalence of your device to a premarket nothreation. - The PDF Innelis 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), II you desire specific advice for your as at (301) 594-4613. Additionally, for questions on please contact the Office of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (2011) 594-4057. Thiso, product at 807.97) you may obtain. Other general information on premainer nouried.roller. your responsibilities and Consumer 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,

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name: GC Initial Dental Porcelain

Indications for Use:

This product is intended for use in fabricating oral crowns, bridges, laminate veneers, inlays and onlays for dental use.

04-0567

Prescription Use
(21 CFR Part 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Betz MD for Dr. Susan Runner

Control. Dental

510(k) Number: K040567

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.