CONCORD 82

K011628 · Gateway Alloys, Inc. · EJT · Jul 16, 2001 · Dental

Device Facts

• Record ID: K011628
• Device Name: CONCORD 82
• Applicant: Gateway Alloys, Inc.
• Product Code: EJT · Dental
• Decision Date: Jul 16, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CONCORD 82 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type IV (Extra Hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span and long-span bridgework.

Device Story

Concord 82 is a yellow gold/platinum dental casting alloy; used by dental laboratory technicians to fabricate dental restorations. Device functions as a restorative material for single units, crowns, and bridgework; specifically designed for high-stress applications and porcelain-fused-to-metal restorations. Material is cast into shape by dental professionals to restore patient dentition; provides structural support and aesthetic base for porcelain. Benefits include durability and suitability for complex, high-stress dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Yellow colored gold/platinum dental casting alloy; classified as Type IV (Extra Hard) alloy. Designed for high-stress dental restorations and porcelain-fused-to-metal applications. No specific ASTM standards or software components described.

Indications for Use

Indicated for dental patients requiring high-stress restorations, including single units, 3/4 crowns, and short-span or long-span bridgework, where porcelain-fused-to-metal or Type IV (Extra Hard) crown and bridge alloy is required.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2001

Mr. John C. Constantine Secretary/Treasurer Gateway Alloys, Incorporated 1702 Scherer Parkway 63303 Saint Charles, Missouri

K011628 Re : Concord 82 Trade/Device Name: 872.3060 Regulation Number: Regulatory Class: II Product Code: EJT Dated: May 29, 2001 Received: May 29, 2001

Dear Mr. Constantine:

We have reviewed your Section 510(k) notification of intent to we have reviewed your beceion beve and we have determined the market the device referenced above and word indications for device is substancially equivaled by marketed predicate use stated in the encrobare, es accessed prior to May 28, 1976, devices marketed in theerbead on Device Amendments, or to
the enactment date of the Medical Device arradongs with the the enactment date of che nassified in accordance with the devices that have been recraobiler, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmete the general provisions of the reacrain toom device, subject to the general controls provisions of the Act. The general controls controls provisions of the requirements for annual provisions of the Act incrace esquestmanufacturing practice, registration, freeing - or a stainst misbranding and adulteration.

If your device is classified (see above) into either class II II your device Is crabbless III (Premarket Approval), it may (Special Controls) of Stippil controls. Existing major be subject to such addreibler can be found in the Code of regulations arrecting your ac vita es 800 to 895. A rederal kegulations, frees to, ination assumes compliance with Substantly equivalence aring Practice requirements, as set the Current Good hands and the System Regulation (QS) for Medical Lorth In the Quarrey Bysoom (21 CFR Part 820) and that, Devices. Ocherar QS inspections, the Food and Drug Chrough Deriodic QB Inbpeoseity such assumptions. Failure to Administration (121) regulation may result in regulatory comply with the orn regaration forther announcements

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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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

K.J. Wilkinson

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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(510 (k) Number: _____________________________________________________________________________________________________________________________________________________________

Device Name: _CONCORD 82

Indications for Use: CONCORD 82 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type IV (Extra Hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span and long-span bridgework.

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| Prescription Use<br>1/<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
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| (Pex 21 CFR 801.109 | |

Over-the-Counter-Use

Suan Kinney

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