(48 days)
CONCORD 72 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require low fusing 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.
CONCORD 72 (PM-41) is a yellow colored gold/platinum dental casting alloy.
The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental casting alloy, "Concord 72." It confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.
While the document includes the device name, regulation number, product code, and indications for use, it does not detail:
- Acceptance criteria for performance.
- Reported device performance against any criteria.
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- How ground truth for the training set was established.
Therefore, I cannot provide the requested table or study details based on the given input.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
Re : K011626 Concord 72 Trade/Device Name: 872.3060 Regulation Number: Regulatory Class: II EJT Product Code: May 29, 2001 Dated: May 29, 2001 Received:
Dear Mr. Constantine:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beooed above and we have determined the market the device ferences as a substant (for the indications for device is bubbeancearly sure) to legally marketed predicate use stated in the cholobare, e commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment accordings first in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the reactar rood bray, and early the general controls provisions of the Act. The general controls concrois provisions of include requirements for annual provisions of the not of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II II your device ID crabins III (Premarket Approval), it may be subject to such additional controls. Existing major be subject to Bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. .A rederal Acguiderence, Iroso termination assumes compliance with subscancially equiralfacturing Practice requirements, as set the Current Sood hands System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodio go mapl verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 – Mr. Constantine
concerning your device in the Eederal Register. Please note: concerning your device in arrantet notification submission does this response to your premaries now under sections 531 not arrect any obingation of the Electronic through 542 of the net roll control or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Infs receir wiri allo(k) premarket notification. The FDA described in your 510 k, premaines of your device to a legally
finding of substantial equivalence of your device for your finding of substancial equivalence or your the morey marketed predicate device rebares in market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 cm Fare over and se contact the Office of Villo diagnostic devices), proubedily, for questions on Compilance at (501) beertising of your device, please contact the promotion and adversibility on John March please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained from the bivision or billian (801) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Klatouski
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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626 バ
(510 (k) Number: _____________________________________________________________________________________________________________________________________________________________
Device Name: _ CQNCORD 72
Indications for Use: CONCORD 72 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require low fusing 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.
(Please do not write below this line)
Supr. Purse
(Division Sign-Off) Division of Dental, Infection Control, ാർ General Hospital Devices ド:行火) Number __
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.