Mosaic is a light-cured, bisGMA-based universal restorative composite. Mosaic is radiopaque and available in multiple shades. It has a nano-hybrid composite containing zirconia-silica glass ceramic and 20 nanometer silica. Filler load is 68% by volume for the dentin shades and 56% for the enamel shades. Mosaic is supplied in multi-use syringes (4.0 grams) and single compules (0.2 grams).

AI/ML Overview

This document describes the premarket notification for the Mosaic™ Universal Composite, a dental resin material. It is a PMA document that focuses on demonstrating substantial equivalence to predicate devices based on chemical, mechanical, and physical properties, as well as intended use and safety. The provided text is a regulatory submission for a dental device, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study design for AI/ML devices, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI/ML algorithm is not applicable to this document. The document pertains to a physical dental material.

Here's an analysis of the provided text in the context of device acceptance, even though it's not an AI/ML device:

Device: Mosaic™ Universal Composite (Tooth Shade Resin Material)
Applicant: Ultradent Products, Inc.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct "acceptance criteria" table in the sense of predefined thresholds for specific performance metrics that the device must meet to be approved. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. This is a common regulatory pathway for Class II medical devices. The performance is reported in terms of characteristics that are compared to the predicates.

Characteristic	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (Mosaic™ Universal Composite)
Intended Use	Functionally equivalent to predicate devices for direct and indirect restorations	Used for direct and indirect restorations (inlays, onlays, and veneers) in both anterior and posterior regions.
Intended User	Licensed dentist (same as predicates)	Licensed dentist
Chemical Characteristics	Bis-GMA based resin (similar to predicates)	Bis-GMA based resin, nano-hybrid composite containing zirconia-silica glass ceramic and 20 nanometer silica.
Delivery System	Similar to predicate systems (compule, syringe)	Compule, syringe
Physical Properties	Similar shelf life, radiopacity, light cure system, and filler load to predicates.	24-month shelf life (room temperature), available in VITA shades, radiopaque, light cure system. Dentin shade: 68% Filled by Volume; Enamel shade: 56% Filled by Volume.
Biocompatibility	Meets ISO 10993 standards (similar to predicates)	Cytotoxicity, Genotoxicity, Delayed-Type Hypersensitivity, Irritation assessed (in accordance with EN ISO 10993-1:2009).
Functional Testing	Meets ISO 4049 standards for polymer-based restorative materials (similar to predicates)	ISO 4049:2009
Risk Analysis	Identified, assessed, and controlled to levels as low as currently feasible, no hazardous residual risks.	Performed utilizing processes based on ISO 14971:2012. Residual risks not considered hazardous.

2. Sample Size Used for the Test Set and Data Provenance:

This document describes a regulatory submission for a physical dental material, not an AI/ML algorithm evaluated on a "test set" of data. Therefore, the concept of a "sample size for the test set" is not applicable in the context of an AI/ML evaluation. The product's performance is based on laboratory testing of the material itself and comparison to established predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This is not applicable as the document is about a material, not an AI/ML system requiring expert-established ground truth from a dataset.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

Not applicable. This is not an AI/ML device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. There is no AI/ML algorithm involved.

7. The Type of Ground Truth Used:

For this dental material, the "ground truth" for its performance and safety is established through:

International Standards: Adherence to standards like ISO 4049:2009 (Dentistry - Polymer-based restorative materials) and EN ISO 10993-1:2009 (Biocompatibility testing).
Laboratory Testing: Physical and chemical properties are measured in a laboratory setting.
Comparison to Predicate Devices: The key "ground truth" for regulatory acceptance here is that the new device is "substantially equivalent" to legally marketed, previously cleared devices, meaning it performs similarly and presents similar safety and effectiveness profiles.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three interconnected profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 21, 2015

Ultradent Products, Inc. Ms. Karen Kakunes, RN Sr. Regulatory Affairs Associate 505 West 10200 South South Jordan, UT 84095

Re: K151094

Trade/Device Name: Mosaic™ Universal Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF Dated: April 22, 2015 Received: April 23, 2015

Dear Ms. Kakunes:

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. Isting 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours. lina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151094

Device Name Mosaic Universal Composite

Indications for Use (Describe)

Mosaic is used for direct and indirect restorations (inlays, onlays, and veneers) in both the anterior regions.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5: 510(k) Summary

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

l. Applicant's Name and Address

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

Contact Person:	Karen Kakunes, RN
Title:	Sr. Regulatory Affairs Associate
Telephone:	800-552-5512 x4420, 801-553-4366
FAX:	801-553-4609
Date Summary Prepared:	17 Jul 2015

II. Name of the Device

Trade Name:	Mosaic™ Universal Composite
Common Name:	Tooth Shade Resin Material
Device Classification:	II
Classification Product Code:	EBF
Regulation No.	21 CFR 872.3690

lll. Legally Marketed Predicate Devices to Which Equivalence is Claimed

Mosaic is substantially equivalent to Filtek™ Supreme Ultra Universal Restorative (K083610) and 3M™ Dent II System (K981647), both of which have been cleared under dental device product code EBF (tooth shade resin material). Mosaic is substantially similar to the predicate devices in Indications for Use, chemical composition, mechanical and physical properties, and application.

IV. Device Description:

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V. Statement of intended use:

Mosaic is used for direct and indirect restorations (inlays, onlays, and veneers) in both the anterior and posterior regions.

VI. Indication of Risk Analysis Method:

Risk Analysis was performed on Mosaic utilizing processes based on ISO 14971:2012. Risks associated to patient safety and product efficacy for Mosaic have been identified, assessed, and controlled to level that is as low as currently feasible. Any remaining residual risks are not considered to be hazardous to patients, customers, and/or end users. Ultradent considers Mosaic to be substantially equivalent in safety and effectiveness in its intended use as compared to the predicate device.

VII. Technological Characteristics and Testing Summary:

The technological characteristics of Mosaic are very similar to those of the predicate devices, 3M™ Dent II System (K981647) and Filtek™ Supreme Ultra Universal Restorative (K083610). Mosaic is a similar product, manufactured with similar or identical materials and used in the same way by the same types of users.

Mosaic has been tested and designed in accordance with ISO 4049:2009 Dentistry -Polymer-based restorative materials. Biocompatibility testing has been assessed according to EN ISO 10993-1:2009.

The device design, delivery form(s) and intended use of Mosaic and the predicate devices are the same or very similar. Based on the technological characteristics and performance testing, Mosaic has demonstrated it is substantially equivalent to the identified predicate device(s).

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Characteristic	Comparison Product(3M Dent II SystemK981647)	Comparison Product(Filtek Supreme UltraUniversal RestorativeK083610)	Mosaic Universal Composite
Intended Use	Direct anterior and posteriorrestorations including:• Class III, IV, V, and VI• Veneers• Incisal edge repairDirect posterior restorationsincluding:• Class I or II• Sandwich technique withglass ionomer resin material• Cusp buildupsCore BuildupsSplintingIndirect anterior and posteriorrestoration including:• Inlays• Onlays• Veneers	Filtek Supreme Ultrauniversal restorative isindicated for use in:• Direct anterior andposterior restorations(including occlusal surfaces)• Core Build-ups• Splinting• Indirect restorationsincluding inlays, onlays andveneers	Mosaic is used for direct andindirect restorations (inlays,onlays, and veneers) in boththe anterior and posteriorregions.
Intended user	Licensed dentist	Licensed dentist	Licensed dentist
ChemicalCharacteristics	Bis-GMA	Bis-GMA, UDMA, TEGDMA,PEGDMA, and Bis-EMA resins	Bis-GMA based resin
Delivery system	Unknown	Capsule, syringe	Compule, syringe
Physicalproperties	36 month shelf life, roomtemperatureRadiopaqueLight Cure System	36 month shelf life, roomtemperatureAvailable in a variety of VITAShadesRadiopaqueEnamel shade: 63.3% Filledby Volume; Translucentshade: 55.6% Filled byVolume	24 month shelf life, roomtemperatureAvailable in a variety of VITAShadesRadiopaqueDentin shade: 68% Filled byVolume; Enamel shade: 56%Filled by VolumeLight Cure System
		Light Cure System
Biocompatibility	ISO 10993	ISO 10993	Cytotoxicity, Genotoxicity,Delayed-TypeHypersensitivity, Irritation
Functional Testing	ISO 4049	ISO 4049:2009	ISO 4049:2009

Table 5-1: Substantial equivalence comparison

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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.