(90 days)
CONCORD 88 (PM-43) 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 III (hard) crown and bridge alloy. It is intended for use in the manufacture of single units, ¾ crowns, and short-span bridgework.
CONCORD 88 (PM-43) is a yellow colored gold/platinum dental casting alloy.
The provided text is a 510(k) premarket notification letter from the FDA for a dental casting alloy named "Concord 88." This document is not a study report for an AI/ML powered medical device, but rather a regulatory approval for a material.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information cannot be extracted from this document, as it pertains to a different type of medical device approval.
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AUG 2 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John C. Constantine Secretary/Treasurer Gateway Alloys, Incorporated 1702 Scherer Parkway Saint Charles, Missouri 63303
Re : K011661 Trade/Device Name: Concord 88 Requlation Number: 872.3060 Regulatory Class: II Product Code: EJT Dated: July 30, 2001 Received: August 21, 2001
Dear Mr. Constantine:
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 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 (Premarket Approval), 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 895. A 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Constantine
this response to your premarket notification submission does this response to your premailor mot have under sections 531 not arrect any obligation for devices under the Electronic Chrough 542 OF the net 20- rovisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Info recei wour 510(k) premarket notification. The FDA described in your 510 m, provilence of your device to a legally illuling of substancial equivalor of plassification for your marketed predicate dovice your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccrrist and additionally 809.10 for in regulation (21 crk rares), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on compriance ac (od advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Obtained from the Divisioner Assistance at its toll-free number Incernational and Combames - 6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamajn.html".
Sincerely yours,
Kj Widorisk
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 88
Indications for Use: CONCORD 88 (PM-43) 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 III (hard) crown and bridge alloy. It is intended for use in the manufacture of single units, ¾ crowns, and short-span bridgework.
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| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K011661 |
Prescription Use (Per 21 CFR 801.109 OR
Over-the-Counter-Use
§ 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.