ORION GX ALLOY by DENTSPLY INTL.

This document describes regulatory correspondence for the ORION GX ALLOY and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document states that the device is "substantially equivalent" to legally marketed predicate devices based on its formulation and historical use in Europe, along with biocompatibility test results. However, it does not provide specific acceptance criteria or details of a study designed to demonstrate performance against those criteria in a structured manner as requested in the prompt.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The closest relevant information is:

Predicate Devices: Degudent H Alloy K821446
Technological Characteristics: "All of the components found in ORION GX ALLOY have been used in legally marketed devices. ORION GX ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1978 with over 1.5 million units placed."
Biocompatibility Testing: "ORION GX ALLOY was tested for Cytotoxicity and AMES mutagenicity and found to be non-cytotoxic and non-mutagenic."

These points serve as the basis for the FDA's substantial equivalence determination, but they are not presented as acceptance criteria with corresponding performance data from a specific study as outlined in the prompt's request.

Summary

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Image /page/0/Picture/1 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The word is slightly stylized, with the "P" having a unique shape where the loop is replaced by a sharp angle.

NAME & ADDRESS:

SEP 3 0 2003

KO32377

NTSPLY Internationa

0 West College Avenue J. Box 872 York, PA 17405-0872 (717) 845-7511 ax +7-7-7-849-4762 www.dentsply.com

P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn CONTACT:

July 25, 2003 DATE PREPARED:

ORION GX ALLOY TRADE OR PROPRIETARY NAME:

Gold-based alloy for clinical use (872.3060) CLASSIFICATION NAME:

PREDICATE DEVICES: Degudent H Alloy K821446

ORION GX ALLOY is a yellow. high noble, gold-based dental DEVICE DESCRIPTION: alloy.

INTENDED USE: ORION GX ALLOY is used for construction of MOD inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain to metal technique.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in ORION GX ALLOY have been used in legally marketed devices.

ORION GX ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1978 with over 1.5 million units placed. ORION GX ALLOY was tested for Cytotoxicity and AMES mutagenicity and found to be non-cytotoxic and non-mutagenic. Therefore, it was determined that no further biocompatibility testing was necessary

We believe that the prior use of the components of ORION GX ALLOY in legally marketed devices, the performance data provided, the biocompatibility test results, and the historical use of the device in Europe support the safety and effectiveness of ORION GX ALLOY for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2003

Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re: K032317

Trade/Device Name: Orion GX Alloy Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 25, 2003 Received: July 28, 2003

Dear Mr. Lehn:

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 (see 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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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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Ronan

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

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INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known):

Device Name:

ORION GX ALLOY

Indications for Use:

Construction of MOD inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.

Mly. U. Su fa NBR

ivision Sinn-Off on of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K032317

(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.