ULTRACROWN 75 ALLOY is indicated for the fabrication of porcelain-fused-to metal single-unit and multiple-unit restorations. / Fabrication of porcelain-fused-to-metal single-unit and multiple-unit restorations

Device Description

ULTRACROWN 75 ALLOY is a gold-based dental alloy. It is highly biocompatible; does not contain nickel, beryllium, cadmium, or cobalt. The alloy is tarnish and corrosion resistant.

AI/ML Overview

This document is a 510(k) summary for a dental alloy, ULTRACROWN 75 ALLOY. It is a premarket notification for a Class II medical device, indicating that its substantial equivalence to a legally marketed predicate device (Degudent LS Alloy, K960256) is being claimed based on similarities in formulation and components, rather than extensive new studies proving novel performance.

Therefore, many of the typical acceptance criteria and study details related to AI/software performance metrics (like sensitivity, specificity, F1-score, reader studies, etc.) are not applicable to this type of submission. This 510(k) focuses on material composition and biocompatibility as the primary areas of concern.

Here's an attempt to answer the questions based on the provided text, acknowledging the nature of this submission:

A table of acceptance criteria and the reported device performance

Given that this is a material modification submission and not a performance-based AI/software device, the "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device, primarily through compositional similarity and prior use of components. The document does not list quantitative performance metrics in the traditional sense for medical device efficacy.

Acceptance Criteria (Inferred from submission)	Reported Device Performance (as stated in the document)
Biocompatibility	"highly biocompatible; does not contain nickel, beryllium, cadmium, or cobalt." "ULTRACROWN 75 ALLOY's formulation is very similar to the predicate device and was not changed in any way that would adversely affect its biocompatibility. Therefore, it was determined that no biocompatibility testing was necessary."
Tarnish and Corrosion Resistance	"The alloy is tarnish and corrosion resistant." (Implicitly, at least as good as the predicate based on compositional similarity)
Suitability for intended use	Indicated for "fabrication of porcelain-fused-to metal single-unit and multiple-unit restorations." (Implicitly, suitable due to compositional similarity to predicate).
Compositional Similarity to Predicate	"Quantitative changes have been made to the device's formulation. All of the components have been used in legally marketed devices." "ULTRACROWN 75 ALLOY represents a modification to DENTSPLY's Degudent LS (K960256)."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A. This submission is for a dental alloy, not a device evaluated through traditional test sets. The "test" here refers to a comparison of its chemical composition against a predicate device and known biocompatibility standards for its constituent materials. No patient data or image data (test set) was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. No ground truth established by experts for a test set in the context of device performance. The evaluation is based on material science principles and regulatory compliance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. No test set or related adjudication method in this submission.
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

N/A. This is not an AI-assisted device. Therefore, no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This is not an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is based on:
- Material composition analysis: Chemical assays for the alloy's constituents.
- Established scientific principles: Regarding biocompatibility, tarnish, and corrosion resistance of specific elements and their combinations in dental alloys.
- Regulatory precedent: The substantial equivalence to the predicate device, Degudent LS Alloy (K960256), which itself would have met certain standards.
- Prior use of components: The components have a history of use in legally marketed devices.
The sample size for the training set

N/A. This device does not involve machine learning or AI, and therefore has no "training set."
How the ground truth for the training set was established

N/A. Similarly, this is not applicable for a dental alloy submission.

Summary

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510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

SEP 2 6 2003

P. J. Lehn Telefax (717) 849

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CONTACT: P. Jeffery Lehn

SEP 1 0 2003 DATE PREPARED:

TRADE OR PROPRIETARY NAME: ULTRACROWN 75 ALLOY

Gold-based alloy for clinical use (872.6090) CLASSIFICATION NAME:

Degudent LS Alloy (K960256) PREDICATE DEVICES:

DEVICE DESCRIPTION: ULTRACROWN 75 ALLOY is a gold-based dental alloy. It is highly biocompatible; does not contain nickel, beryllium, cadmium, or cobalt. The alloy is tarnish and corrosion resistant.

ULTRACROWN 75 ALLOY is indicated for the fabrication of INTENDED USE: porcelain-fused-to metal single-unit and multiple-unit restorations.

TECHNOLOGICAL CHARACTERISTICS: ULTRACROWN 75 ALLOY represents a modification to DENTSPLY's Degudent LS (K960256). Quantitative changes have been made to the device's formulation. All of the components have been used in legally marketed devices.

ULTRACROWN 75 ALLOY's formulation is very similar to the predicate device and was not changed in any way that would adversely affect its biocompatibility. Therefore, it was determined that no biocompatibility testing was necessary.

We believe that the prior use of the components in legally marketed devices, the similarities in the formulation between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of ULTRACROWN 75 ALLOY for the intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three curved lines, possibly representing a stylized human form or a symbol of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2003

Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue York, Pennsylvania 17404

Re: K032851

Trade/Device Name: Ultracrown 75 Alloy Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical use Regulatory Class: II Product Code: EJT Dated: September 10, 2003 Received: September 12, 2003

Dear Mr. Lehn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. Lehn

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(c)

510(K) Number (if known):

K032851

Device Name:

ULTRACROWN 75 ALLOY

Indications for Use:

Fabrication of porcelain-fused-to-metal single-unit and multiple-unit restorations

Mly U. Settle for MSR

510(k) Numbe

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.