FORMA Composite is designed for restorations in anterior and posterior teeth.
FORMA™ Composite is used for direct and indirect restorations in both the anterior and posterior regions.

Device Description

FORMA™ Composite is a Bis-GMA-based restorative composite. FORMA™ composite is designed for restorations in anterior and posterior teeth and is suitable for occlusal surfaces. Its formula contains a zirconia/silica inorganic filler combination and barium glass. FORMA™ composite is shaded based on the VITA shade guide, and is radiopaque. FORMA™ composite has a radiopacity value greater than 2 mm of aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material having a radiopacity equivalent to 1 mm of aluminum has a radiopacity equivalent to that of dentin and 2 mm of aluminum is equivalent to enamel.
FORMA™ composite A3D is filled 78% w/w. FORMA™ composite is a nanohybrid composite with nanoparticles entombed within the composite's formulation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental composite material called FORMA Composite. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device, not a study performing statistical comparisons for AI/ML performance.

Therefore, the information required to answer most of your numbered points (especially those related to AI/ML device study parameters like sample size for testing/training set, expert ground truth establishment, MRMC studies, or standalone algorithm performance) is not present in the provided document.

The document focuses on the physical, chemical, and biological properties of the dental composite, and its comparison to a predicate device, as required for a Class II dental device submission. It does not describe an AI/ML medical device.

However, I can extract the following information that is relevant to "acceptance criteria" and "proof of meeting criteria" as it relates to this dental composite device:

1. A table of acceptance criteria and the reported device performance:

The document outlines physical properties that serve as "acceptance criteria" by comparing the subject device (FORMA Composite) to the predicate device and asserting compliance with ISO standards.

Acceptance Criteria (Physical Properties - derived from Predicate/ISO 4049 compliance)	Subject Device: FORMA Composite Performance
Depth of Cure ≥1.5mm	≥1.5mm (Implied by "Similar – ISO 4049 Compliant")
Curable wavelength 385-515nm	385-515nm (Implied by "Similar – ISO 4049 Compliant")
Curing Intensity ≥800 mW/cm²	≥800 mW/cm² (Implied by "Similar – ISO 4049 Compliant")
Curing Time 10s per layer, 20s final cure	10s per layer, 20s final cure (Implied by "Similar – ISO 4049 Compliant")
Flexural Strength ≥80 MPa	≥80 MPa (Implied by "Similar – ISO 4049 Compliant")
Filler particle size (range provided for subject device: 0.014-3µm)	0.014-3µm (Specific to subject device)
Water sorption ≤40 µg/mm³	≤40 µg/mm³ (Implied by "Similar – ISO 4049 Compliant")
Water solubility ≤7.5 µg/mm³	≤7.5 µg/mm³ (Implied by "Similar – ISO 4049 Compliant")
Radio-Opacity ≥1mm of Al	≥1mm of Al (Implied by "Similar – ISO 4049 Compliant")
Surface Hardness ≥50.0 HK	≥50.0 HK (Implied by "Similar – ISO 4049 Compliant")
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Implantation Effects, Genotoxicity)	Evaluated according to ISO 7405:2018 and ISO 10993-1:2018. Tests conducted and other evaluations done.
Usability/Simulated Use	Met predefined user needs and indications for use.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified in terms of number of experimental units (e.g., number of samples for each physical test). The document states "Full testing to ISO 4049:2019, surface hardness evaluation, drop test ship testing, and an assessment on the curing wavelength, curing intensity and curing time were completed for the product verification testing." It also mentions "Simulated use and validation testing was conducted by dental professionals." The specific number of tests or samples is not provided.
Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing performed by Ultradent Products, Inc. (manufacturer). No country of origin for data is mentioned. The testing is implied to be prospective, as it was conducted for this specific submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of defining "ground truth" for a physical dental composite.
"Dental professionals" were used for "simulated use and validation testing," but their number and specific qualifications (other than being dental professionals) are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is for consensus-based labeling or image interpretation, not physical product testing.

5. 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:

No. This is a dental composite material, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a dental composite material, not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For physical/chemical properties: Standardized Laboratory Testing/Measurements according to ISO standards (e.g., ISO 4049:2019 for dentistry - polymer-based restorative materials, and ISO 7405:2018 and ISO 10993-1:2018 for biological evaluation). The "ground truth" is established by the methods outlined in these international standards.
For usability: Simulated use by dental professionals validated against predefined user needs and indications for use.

8. The sample size for the training set:

Not applicable. This document describes a traditional medical device (dental composite), not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. See point 8.

In summary, the provided document details the regulatory submission for a physical dental material and does not contain information related to AI/ML device studies or their associated evaluation metrics and methodologies.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

March 15, 2024

Ultradent Products, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K240694

Trade/Device Name: FORMA Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: March 12, 2024 Received: March 14, 2024

Dear Dave Yungvirt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240694

Device Name FORMA Composite

Indications for Use (Describe)	FORMA Composite is designed for restorations in anterior and posterior teeth.
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Type of Use (Select one or both, as applicable)

Remediation Use (Part 21 CFR 221, Subpart D)
Cosmetic Use (21 CFR 221, Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912

510(k) Summary

This summary of the 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 FORMA Composite.

I. Applicant's Name and Address

Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095

Contact Person:	Adam Black
Title:	Senior Manager - Regulatory Affairs
Telephone:	801-553-4425
Email:	adam.black@ultradent.com
Date Summary Prepared:	March 11, 2024

II. Name of the Device

Device:	FORMA Composite
Trade/Device Name:	FORMA Composite (Shade A3D)
Common Name:	Tooth Shade, Resin
Review Panel:	Dental
Regulation Number:	21 CFR 872.3690
Device Class:	Class II
Product Code(s):	EBF

III. Device Description

FORMA™ composite A3D is filled 78% w/w. FORMA™ composite is a nanohybrid composite with nanoparticles entombed within the composite's formulation.

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Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912

IV. Statement of Intended Use

FORMA™ Composite is used for direct and indirect restorations in both the anterior and posterior regions.

V. Predicate Device

Predicate Identified: Mosaic Universal Composite K151094

VII. Comparison of Technological Characteristics

Predicate technological comparison:

The predicate and subject device have the same technological characteristics, which is primarily the design as a light-curable dental composite material which is available in a reusable syringe and single-use capsule presentation. The primary difference between the subject and predicate device is in the chemical composition which was adjusted for handling and shading. These differences and similarities have been evaluated below in Table 1:

Table 1

DescriptiveInformation	Subject Device: FORMA Composite	Predicate: Mosaic UniversalComposite (K151094)	Explanation ofDifferences
Product Code	EBF	EBF	N/A – Identical productcode
Indications forUse	FORMA™ Composite is used fordirect and indirect restorations inboth the anterior and posteriorregions.	Mosaic composite is used for directand indirect restorations (inlays,onlays, and veneers) in both theanterior and posterior regions.	The removal of theexamples of indirectrestoration types "inlays,onlays, and veneers" doesnot impact the safety orperformance as thisinformation was only toprovide smallclarification.
Principle ofOperation	Mechanical leverage is used toexpress composite. The uniquechemical structure of FORMA	Mechanical leverage is used toexpress composite. The uniquechemical structure of Mosaic allows	N/A – Identical principlesof operation
DescriptiveInformation	Subject Device: FORMA Composite	Predicate: Mosaic UniversalComposite (K151094)	Explanation ofDifferences
	Composite allows for the chemistryto be placed into preformedcavities in the tooth structure torebuild the physical structure of theremoved dentin. The formulationcontains photoinitiators that causepolymerization of the moldablechemistry. Once the device ispolymerized, it exhibits mechanicaland physical behaviors similar tothat of natural dentition.	for the chemistry to be placed intopreformed cavities in the toothstructure to rebuild the physicalstructure of the removed dentin. Theformulation contains photoinitiatorsthat cause polymerization of themoldable chemistry. Once the deviceis polymerized, it exhibitsmechanical and physical behaviorssimilar to that of natural dentition.
Intended User	Dentist or dental professional	Dentist or dental professional	N/A – Identical IntendedUser
Delivery System	4g Reusable Syringe or 0.2g single-use capsule	4g Reusable Syringe or 0.2g single-use capsule	N/A – Identical deliverysystem offerings
Composition ofMaterials	Bis-GMA, TEGDMA, Bis-EMA, andUDMA basePhotoinitiators (Camphorquinone)Silanated GlassSilica	Bis-GMA, TEGDMA, UDMA basePhotoinitiators (Camphorquinone)Silanated GlassSilica	Similar – Base materialhas been adjusted forhandling and to achieveproper shade.
PhysicalProperties	Depth of Cure ≥1.5mmCurable wavelength 385-515nmCuring Intensity ≥800 mW/cm²Curing Time 10s per layer, 20sfinal cureFlexural Strength ≥80 MPaFiller particle size 0.014-3µmWater sorption ≤40 µg/mm³Water solubility ≤7.5 µg/mm³Radio-Opacity ≥1mm of AlSurface Hardness ≥50.0 HK	Depth of Cure ≥1.5mmCurable wavelength 385-515nmCuring Intensity ≥800 mW/cm²Curing Time 10s per layer, 20sfinal cureFlexural Strength ≥80 MPaFiller particle size* ≥0.02µmWater sorption ≤40 µg/mm³Water solubility ≤7.5 µg/mm³Radio-Opacity ≥1mm of AlSurface Hardness ≥50.0 HK	Similar – ISO 4049Compliant
FDA RecognizedStandards	ISO 7405: 2018ISO 4049:2019IEC 62366-1:2020ISO 14971:2019ISO 10993-1:2018ISO 15223-1:2021ISO 7491-2000	ISO 7405: 2018ISO 4049:2009IEC 62366-1:2015ISO 14971:2012ISO 10993-1:2018ISO 7491:2000	Similar – Addition of ISO15223-1 based on use ofsymbols

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Image /page/5/Picture/1 description: The image shows the address and contact information for Ultradent Products, Inc. The address is 505 West Ultradent Drive (10200 South), South Jordan, UT 84095. The establishment registration number is 1718912. The image also includes the Ultradent logo.

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Image /page/6/Picture/1 description: The image shows the Ultradent Products, Inc. logo and company information. The logo is an orange square with the letters "UP" in white. Below the logo is the word "ULTRADENT" in white. The company address is listed as "lent Drive (10200 South) South Jordan, UT 84095".

505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912

VIII Non-Clinical Performance Testing:

Verification and validation testing was performed to show that the subject device is substantially equivalent to the currently marketed predicate device, Mosaic Universal Composite. Full testing to ISO 4049:2019, surface hardness evaluation, drop test ship testing, and an assessment on the curing wavelength, curing intensity and curing time were completed for the product verification testing.

Simulated use and validation testing was conducted by dental professionals to confirm that all aspects from usability assessments and risk management were implemented in the labeling and the design of the device itself. The conclusion of this validation testing confirmed that the subject device met the predefined user needs and the indications for use, which are identical to the predicate device. Thus the verification and validation support the conclusion that the subject device, FORMA Composite, is substantially equivalent to the predicate device, Mosaic Universal Composite (K151094).

IX Biocompatibility Assessment

FORMA Composite has been evaluated for applicable biological risks associated to the device type according to ISO 7405:2018 and ISO 10993-1:2018. Cytotoxicity, Sensitization, and Irritation tests were conducted according to applicable ISO 10993 series standards. Other applicable biological endpoints (Systemic Toxicity, Implantation Effects, and Genotoxicity) were evaluated utilizing available literature, chemical characterization testing and other biocompatibility tests available for the device and its constituents.

Conclusion:

The predicate and subject devices have identical indications for use with a slight variation to remove the examples of indirect restoration types. The differences between the predicate and subject device have been evaluated with established methods, including testing to ISO 4049, biological risk evaluations according to ISO 10993-1, and product packaging assessments. Based on the testing and evaluation of the subject device, FORMA Composite, as compared to the predicate device, Mosaic Universal Composite (K151094), the conclusion can be made that FORMA Composite is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.