Mosaic Universal Composite

K151094 · Ultradent Products, Inc. · EBF · Jul 21, 2015 · Dental

Device Facts

• Record ID: K151094
• Device Name: Mosaic Universal Composite
• Applicant: Ultradent Products, Inc.
• Product Code: EBF · Dental
• Decision Date: Jul 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Mosaic is a light-cured, bisGMA-based universal restorative composite; used by licensed dentists in clinical settings for direct and indirect dental restorations (inlays, onlays, veneers). The device consists of a nano-hybrid composite containing zirconia-silica glass ceramic and 20 nanometer silica fillers. It is supplied in multi-use syringes or single-use compules. The clinician applies the material to the tooth structure, which is then hardened via a light-cure system. The radiopaque nature of the composite allows for post-procedural radiographic assessment. By restoring tooth structure, the device aids in maintaining dental function and aesthetics.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 4049:2009 (Dentistry - Polymer-based restorative materials). Biocompatibility assessed per EN ISO 10993-1:2009, including cytotoxicity, genotoxicity, delayed-type hypersensitivity, and irritation testing. No clinical data provided.

Technological Characteristics

Light-cured, bisGMA-based nano-hybrid composite. Fillers: zirconia-silica glass ceramic and 20nm silica. Filler load: 68% (dentin) or 56% (enamel) by volume. Radiopaque. Delivery: multi-use syringes or single-use compules. Standards: ISO 4049:2009 (functional), EN ISO 10993-1:2009 (biocompatibility).

Indications for Use

Indicated for direct and indirect dental restorations, including inlays, onlays, and veneers, in both anterior and posterior regions for patients requiring restorative dental care.

Regulatory Classification

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.

Predicate Devices

• Filtek™ Supreme Ultra Universal Restorative (K083610)
• 3M™ Dent II System (K981647)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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*)

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> 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:

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).

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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<br>(3M Dent II System<br>K981647) | Comparison Product<br>(Filtek Supreme Ultra<br>Universal Restorative<br>K083610) | Mosaic Universal Composite |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Direct anterior and posterior<br>restorations including:<br>• Class III, IV, V, and VI<br>• Veneers<br>• Incisal edge repair<br><br>Direct posterior restorations<br>including:<br>• Class I or II<br>• Sandwich technique with<br>glass ionomer resin material<br>• Cusp buildups<br><br>Core Buildups<br><br>Splinting<br><br>Indirect anterior and posterior<br>restoration including:<br>• Inlays<br>• Onlays<br>• Veneers | Filtek Supreme Ultra<br>universal restorative is<br>indicated for use in:<br>• Direct anterior and<br>posterior restorations<br>(including occlusal surfaces)<br>• Core Build-ups<br>• Splinting<br>• Indirect restorations<br>including inlays, onlays and<br>veneers | Mosaic is used for direct and<br>indirect restorations (inlays,<br>onlays, and veneers) in both<br>the anterior and posterior<br>regions. |
| Intended user | Licensed dentist | Licensed dentist | Licensed dentist |
| Chemical<br>Characteristics | Bis-GMA | Bis-GMA, UDMA, TEGDMA,<br>PEGDMA, and Bis-EMA resins | Bis-GMA based resin |
| Delivery system | Unknown | Capsule, syringe | Compule, syringe |
| Physical<br>properties | 36 month shelf life, room<br>temperature<br><br>Radiopaque<br><br>Light Cure System | 36 month shelf life, room<br>temperature<br><br>Available in a variety of VITA<br>Shades<br><br>Radiopaque<br><br>Enamel shade: 63.3% Filled<br>by Volume; Translucent<br>shade: 55.6% Filled by<br>Volume | 24 month shelf life, room<br>temperature<br><br>Available in a variety of VITA<br>Shades<br><br>Radiopaque<br><br>Dentin shade: 68% Filled by<br>Volume; Enamel shade: 56%<br>Filled by Volume<br><br>Light Cure System |
| | | Light Cure System | |
| Biocompatibility | ISO 10993 | ISO 10993 | Cytotoxicity, Genotoxicity,<br>Delayed-Type<br>Hypersensitivity, Irritation |
| Functional Testing | ISO 4049 | ISO 4049:2009 | ISO 4049:2009 |

## Table 5-1: Substantial equivalence comparison

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