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Found 31 results
510(k) Data Aggregation
(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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(90 days)
GPW-SF is a high fusing white colored gold based solder for brazing porcelain-fused-to-metal alloys prior to the application and firing of the porcelain enamel. It is intended for use in the manufacture of single units, short-span and long-span bridges.
GPW-SF Solder
This is a 510(k) clearance letter for a dental solder, GPW-SF Solder, not a study evaluating a medical device's performance against acceptance criteria. Therefore, I cannot extract the requested information as it is not present in the provided text.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices for its intended use, which is a regulatory decision rather than a performance study. It states:
- Device Name: GPW-SF Solder
- Intended Use: "GPW-SF is a high fusing white colored gold based solder for brazing porcelain-fused-to-metal alloys prior to the application and firing of the porcelain enamel. It is intended for use in the manufacture of single units, short-span and long-span bridges."
The letter does not contain:
- A table of acceptance criteria or reported device performance.
- Information on sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.
- Any description of a study conducted to demonstrate the device meets specific performance criteria.
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(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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(48 days)
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.
Not Found
This document is a 510(k) premarket notification from the FDA, granting clearance for a dental casting alloy named "Concord 82". It does not describe any acceptance criteria for a device, nor does it present any study data demonstrating the device meets such criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance and testing data.
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(34 days)
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(21 days)
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