CENTURY ALLOY by DENTSPLY INTL. | FDA 510(k) Summary

This 510(k) summary for DENTSPLY's 21st CENTURY ALLOY is quite old (1997) and for a dental amalgam alloy, not a software device or a diagnostic device typically associated with AI/ML and the detailed performance studies described in your query.

Therefore, much of the requested information, such as multi-reader multi-case studies, ground truth establishment methodologies for image data, and AI-specific metrics, is not applicable to this submission.

However, I can extract the closest analogous information based on the provided text.

Acceptance Criteria and Device Performance for 21st CENTURY ALLOY (Dental Amalgam Alloy)

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Material Composition	Identical metallic elements and elemental proportions to commercially used alloys over the past 25 years.	21st CENTURY ALLOY contains metallic elements and elemental proportions identical to that commercially used in the past 25 years. Such alloys have historically been proven to be safe and effective as dental restorative materials.
Biocompatibility - Acute Oral Toxicity	Equivalency to other currently distributed dental amalgam alloys.	All tests showed equivalency to other currently distributed dental amalgam alloy.
Biocompatibility - Mutagenicity	Equivalency to other currently distributed dental amalgam alloys.	All tests showed equivalency to other currently distributed dental amalgam alloy.
Biocompatibility - Cytotoxicity	Equivalency to other currently distributed dental amalgam alloys.	All tests showed equivalency to other currently distributed dental amalgam alloy.
Biocompatibility - Pulpal Irritation	Equivalency to other currently distributed dental amalgam alloys.	All tests showed equivalency to other currently distributed dental amalgam alloy.
Intended Use	Suitable for stress-bearing Class 1 and Class 2 restorations.	Designed for stress-bearing Class 1 and Class 2 restorations. The prior use of components, performance data, and biocompatibility testing support the safety and effectiveness for the intended uses.
Substantial Equivalence	Substantially equivalent to legally marketed predicate devices.	Determined substantially equivalent to devices marketed prior to May 28, 1976 (e.g., Valiant® Amalgam Alloy, Dispersalloy® Dispersed Phase Alloy). The FDA's review of the 510(k) notification resulted in a finding of substantial equivalence.

Study Details and Data Provenance (Non-Applicable/Inferred for a 1997 Dental Amalgam)

Sample sizes used for the test set and the data provenance: Not explicitly stated. For material testing of this nature, samples of the alloy would have been manufactured and then subjected to the various biocompatibility tests. The provenance is internal to the manufacturer's testing or contracted labs (assumed for a 1997 submission), and would be prospective testing of the manufactured alloy. It's not "data provenance" in the sense of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For material performance and biocompatibility tests like these, "ground truth" is established by the results of standardized laboratory tests and expert interpretation of those lab results (e.g., toxicologists, histopathologists). The specific number and qualifications of experts are not reported in this summary.
Adjudication method for the test set: Not applicable. This refers to the process of resolving discrepancies in expert interpretations, common in diagnostic image analysis. For material testing, results are typically quantitative or qualitative based on established protocols.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI/ML diagnostic devices. This device is a dental restorative material.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth would be based on standardized laboratory test results interpreted by qualified scientific and medical professionals (e.g., assays for cytotoxicity, animal models for oral toxicity and pulpal irritation). For material equivalency, it relies on elemental analysis and comparison to known compositions of predicate devices, coupled with historical evidence of safety and effectiveness for those materials.
The sample size for the training set: Not applicable. There is no training set for a traditional material like this in the context of machine learning. The "training" in a broader sense comes from decades of historical use and scientific understanding of amalgam alloys.
How the ground truth for the training set was established: Not applicable. As above, no training set in the AI sense. The "ground truth" for the principles behind the material's composition and use is established through long-standing dental material science, clinical consensus, and regulatory standards for such restorative materials.

Summary

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510(k) SUMMARY

DEC 17 1997

Image /page/0/Picture/2 description: The image shows the word "Dentsply" in a bold, stylized font. The letters are all capitalized and connected to each other. The font is sans-serif and has a slightly angled appearance. The word is black and the background is white.

NAME & ADDRESS:

K974035

DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872

(717) 845-7511 Fax (717) 854-2343

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

CONTACT: P. Jeffery Lehn

October 22, 1997 DATE PREPARED:

TRADE OR PROPRIETARY NAME: 21st CENTURY ALLOY

872.3050 - amalgam alloy CLASSIFICATION NAME:

K801690 PREDICATE DEVICE: Valiant® Amalgam Alloy Dispersalloy® Dispersed Phase Alloy Pre-1977

DEVICE DESCRIPTION AND INTENDED USE: 21st CENTURY ALLOY is a lathe cut, silver-based dental amalgam alloy designed for stress-bearing Class 1 and Class 2 restorations.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in 21st CENTURY ALLOY have been used in legally marketed devices. 2185 CENTURY ALLOY contains those metallic elements and elemental proportions identical to that commercially used in the past 25 years. Such alloys have historically been proven to be safe and effective as dental restorative materials.

21st CENTURY ALLOY was tested for Acute Oral Toxicity, Mutagenicity, Cytotoxicity, and Pulpal Irritation. All tests showed equivalency to other currently distributed dental amalgam alloy.

We believe that the prior use of the components of 21st CENTURY ALLOY in legally marketed devices, the performance data, and the results of biocompatibility testing support the safely and effectiveness of 21st CENTURY ALLOY for the intended uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1997

Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405

K974035 Re: Trade Name: Century Alloy Requlatory Class: II Product Code: EJJ Dated: October 22, 1997 Received: October 24, 1997

Dear Mr. Lehn:

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 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 reqistration, listinq of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Lehn

not affect any obligation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to beqin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Clatrust

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

K979035

Device Name:

_21st CENTURY ALLOY

21°T CENTURY ALLOY is a dental alloy designed for stress-bearing

Class 1 and Class 2 restorations.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K074035
Prescription Use	Yes
	OR
	Over-The-Counter Use No

000007

Regulation Number and Section

§ 872.3070 Dental amalgam, mercury, and amalgam alloy.

(a)
Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”See § 872.1(e) for the availability of this guidance document.