nuance UNIVERSAL

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 24, 2017 Den-mat Holdings, LLC Helen Ragus Regulatory Specialist 1017 W. Central Avenue Lompoc, California 93436 Re: K162967 Trade/Device Name: Nuance UNIVERSAL Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 5, 2017 Received: January 5, 2017 Dear Helen Ragus: 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. 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. 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 devicerelated 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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, Susan Runno DDS, MA Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Device Name nuance® UNIVERSAL Indications for Use (Describe) 1) Direct restorations of anterior or posterior teeth (Class I - Class V) 2) Diastema closures 3) Intraoral repairs of fractured crowns/bridges 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for DenMat, a dental supply company. The logo features the letters "dm" in a stylized font, with the "d" in a light blue color and the "m" in a darker blue. Below the letters "dm" is the word "DenMat" in a smaller, darker blue font. The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products. 1017 West Central Avenue Lompoc, CA 93436 805-346-3700 www.denmat.com #### 510(k) SUMMARY V. # Submitter: Owner's Name: 1017 W. Central Avenue Address: Lompoc, CA 93436 U.S.A. . Phone Number: 805 346 3700 805 347 7940 Fax Number: Contact Person: Helen Ragus Regulatory Specialist 805 346 3700, X2932 hragus@denmat.com October 21, 2016 Date of Summary Preparation: Device Name: nuance® UNIVERSAL Trade Name: Light-Curable Dental Restorative Common Name: Material Material, Tooth Shade Resin Classification Name: (21 CFR 872.3690) Den-Mat Holdings, LLC # Predicate Devices: | KURARAY MEDICAL INC. | K063595 | CLEARFIL MAJESTY | |----------------------|---------|------------------| | | | Posterior | {4}------------------------------------------------ #### Description of the Device nuance® UNIVERSAL is a Class II medical device, under Classification 21 CFR 872.3690. Product Code EBF. intended to be used as a composite tooth restorative. The device falls within the scope of guidance document, "Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions. According to the applicable FDA recognized consensus standard, ISO 4049 - "Dentistry - Polymer-based restorative materials, this device is classified as Class 2: materials whose setting is affected by the application of energy from an external source, such as blue light or heat (Group 2). nuance® UNIVERSAL is used in direct restorations of anterior or posterior teeth. They are polymerizable dental monomer resins that are chemically-cured when exposed to dental curing lights. It is used to form a durable, aesthetic restoration. It is a higher viscosity material to be used where mechanical strength is a primary importance. nuance® UNIVERSAL may be appropriate for dental Class I, II, III, IV and V type restorations. nuance® UNIVERSAL is packaged in a 4 gram single-barrel syringe, a 0.35 gram singules, and offered in 11 shades listed below: | Trade Name (Proprietary Name) | Model<br>Numbers | |-----------------------------------------------------|------------------| | nuance® UNIVERSAL A1 – Syringe, 4.0 grams | CR1101 | | nuance® UNIVERSAL A2 – Syringe, 4.0 grams | CR1102 | | nuance® UNIVERSAL A3 – Syringe, 4.0 grams | CR1103 | | nuance® UNIVERSAL A3.5 – Syringe, 4.0 grams | CR1104 | | nuance® UNIVERSAL B1 – Syringe, 4.0 grams | CR1108 | | nuance® UNIVERSAL B2 – Syringe, 4.0 grams | CR1109 | | nuance® UNIVERSAL C3 – Syringe, 4.0 grams | CR1112 | | nuance® UNIVERSAL BL – Syringe, 4.0 grams | CR1106 | | nuance® UNIVERSAL OA2 – Syringe, 4.0 grams | CR1121 | | nuance® UNIVERSAL Dentin 1 - Syringe, 4.0 grams | TBD | | nuance® UNIVERSAL Dentin 2 - Syringe, 4.0 grams | TBD | | nuance® UNIVERSAL A1 – 16 X 0.35 gram singule | CR1135 | | nuance® UNIVERSAL A2 – 16 X 0.35 gram singule | CR1136 | | nuance® UNIVERSAL A3 – 16 X 0.35 gram singule | CR1137 | | nuance® UNIVERSAL A3.5 – 16 X 0.35 gram singule | CR1138 | | nuance® UNIVERSAL B1 – 16 X 0.35 gram singule | CR1142 | | nuance® UNIVERSAL B2 – 16 X 0.35 gram singule | CR1143 | | nuance® UNIVERSAL C3 – 16 X 0.35 gram singule | CR1146 | | nuance® UNIVERSAL BL - 16 X 0.35 gram singule | CR1140 | | nuance® UNIVERSAL OA2 – 16 X 0.35 gram singule | CR1155 | | nuance® UNIVERSAL Dentin 1 – 16 X 0.35 gram singule | TBD | | nuance® UNIVERSAL Dentin 2 – 16 X 0.35 gram singule | TBD | ### Intended Use of the Device nuance® UNIVERSAL is intended to be used as a composite tooth restorative. {5}------------------------------------------------ #### Indications for Use of the Device nuance® UNIVERSAL is recommended for the following types of applications: - 1) Direct restorations of anterior or posterior teeth (Class I Class V) - 2) Diastema closures - 3) Intraoral repairs of fractured crowns/bridges #### Substantial Equivalence Discussion - 1) Intended Uses/Indications for Use nuance® UNIVERSAL and the predicate device CLEARFIL MAJESTY Posterior are both intended to be used as a composite tooth restorative. nuance® UNIVERSAL and the predicate device CLEARFIL MAJESTY Posterior are recommended for the following types of applications: direct restorations of anterior or posterior teeth (Class I - V), diastema closures and intra-oral repairs of fractured crowns and bridges. The intended uses and indications for use of the subject device are substantially equivalent to that of the predicate device. - 2) Chemical Components/Safety Chemical components in nuance® UNIVERSAL are used in the predicate device. The difference between nuance UNIVERSAL and the predicate device is limited to a slight formulation change - the predicate device uses titanium dioxide as the sole white pigment/opaquer used in color adjustment of the final device. In addition to titanium dioxide. nuance® UNIVERSAL contains zinc oxide as a partial replacement for the white pigment/opaque. This change does not raise different questions of safety and effectiveness than the predicate device. The predicate device has not been a focus of any advisory notice or recalls according to the post-market adverse event reporting requirements in the United States. The conclusion can be made that the safety of the subject device is substantially equivalent to that of the predicate device. 3) Technological Characteristics/Effectiveness and Performance nuance UNIVERSAL and the predicate device CLEARFIL MAJESTY Posterior were both tested according to the applicable FDA recognized standard ISO 4049 Dental --polymer based restorative materials. This standard specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth and for luting. The difference between nuance® UNIVERSAL and the predicate device is limited to a slight formulation change - the predicate device uses titanium dioxide as the sole white {6}------------------------------------------------ pigment/opaquer used in color adjustment of the final device. In addition to titanium dioxide, nuance® UNIVERSAL contains zinc oxide as a partial replacement for the white pigment/opaque. This change does not raise different questions of safety and effectiveness than the predicate device. Testing results indicate that nuance® UNIVERSAL was as effective and performs as good as the predicate device. The conclusion can be made that the effectiveness and performance of the subject device is substantially equivalent to that of the predicate device. #### Biocompatibility According to ISO 10993 Biological Evaluation and Biocompatibility Testing of Medical Devices Part 1: Evaluation and testing within a risk management process, the subject device is categorized as an external communicating device with contact to tissue/bone/dentin and is a permanent contact device. nuance UNIVERSAL's chemical composition as well as materials and technological properties is substantially equivalent to that of the predicate device. Both devices are made of materials with a long history of safe use. Biocompatibility of the predicate device was established according to an evaluation of chemical ingredients of the devices used as predicates for its premarket notification. nuance UNIVERSAL's materials are used in the predicate device with the same type and duration of patient contact. These materials have been used in the dental industry for several decades, and therefore, a history of safe use. In addition to nuance UNIVERSAL's biocompatibility substantial equivalence to the predicate device, DenMat has submitted the materials for cytotoxicity test according to ISO 10993 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity with the conclusion that. "the test article was not considered to have a cytotoxic effect (no reactivity)". Test Report 16H0658S-M01 Cytotoxicity is provided in Attachment L. The predicate device has not been a focus of any advisory notice or recalls according to the post-market adverse event reporting requirements in the United States. Available studies from scientific literatures further support the biocompatibility of nuance® UNIVERSAL. | ISO-4049 Dental --- polymer-based restorative materials: Test Results | | | | |-----------------------------------------------------------------------|----------------------|----------------------|----------------------------------| | | Requirement | nuance®<br>UNIVERSAL | CLEARFIL<br>MAJESTY<br>Posterior | | Sensitivity to ambient<br>light | >60 seconds, no cure | pass | pass | | Depth of cure | > 0.5 mm | 5.588 | 5.550 | | Flexural strength | >80 Mpa | 98.7 Mpa | 83.4Mpa | | Water sorption/solubility | ≤ 40 micrograms/mm^3 | 23.3/2.8 | 24.9/2.7 | | Shade/color stability | match standard | match/pass | match/pass | | Radio opacity | ≥ 1.0 mm aluminum | 2 mm | 2 mm | # Comparative Performance Data {7}------------------------------------------------ | Product | 510(k) | Dental Applications* | Chemical<br>Composition | Material<br>Properties | |----------------------------------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | nuance®<br>UNIVERSAL | | - direct restorations of<br>anterior or posterior<br>teeth<br>- diastema closures<br>- intra-oral repairs of<br>fractured crowns and<br>bridges | - Light-cure<br>- Methacrylate<br>resin based<br>- White<br>pigment/<br>opaquer/anti-<br>bacterial agent | - accurate color<br>matching<br>- resistance to<br>abrasion<br>- high strength<br>- polishable<br>- radiopaque | | CLEARFIL<br>MAJESTY<br>Posterior | K063595 | - direct restorations of<br>anterior or posterior<br>teeth<br>- diastema closures<br>- intra-oral repairs of<br>fractured crowns and<br>bridges | - Light-cure<br>- Methacrylate<br>resin based<br>- White<br>pigment/<br>opaquer | - accurate color<br>matching<br>- resistance to<br>abrasion<br>- high strength<br>- polishable<br>- radiopaque | Summary of Features and Characteristics of the Device Compared to the Predicate Device: * - All listed Dental Applications are commonly used dental restorative material applications. | Device Risks and Recommended Mitigation Measures | | |--------------------------------------------------|------------------------| | Identified Risks | Recommended Mitigation | | Identified Risks | Recommended Mitigation Measures | |--------------------------------------|-----------------------------------------------------| | Mechanical Failure | Composition and physical property<br>specifications | | Toxicity and Adverse Tissue Reaction | Biocompatibility | | Improper Use | Device labeling | ### Conclusion The information provided in this 510(k) submission demonstrates that nuance® UNIVERSAL is substantially equivalent to the predicate device CLEARFIL MAJESTY Posterior in terms of intended use, indications for use, chemical composition and physical properties.