Premier's MultiMatch Universal Chameleon Restorative Composite

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December 6, 2022 Premier Dental Products Company % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K223632 Trade/Device Name: Premier's MultiMatch Universal Chameleon Restorative Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: December 3, 2022 Received: December 5, 2022 Dear Prithul Bom: 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. {1}------------------------------------------------ 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, M.ChE. 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 {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K223632 Device Name Premier's MultiMatch Universal Chameleon Restorative Composite Indications for Use (Describe) Premier's MultiMatch Universal Chameleon Restorative Composite is a nano-hybrid dental restorative intended for direct placement in all cavity classes in anterior teeth. Additional indications include repair of enamel defects, repair of provisionals, and repair of porcelain restorations, minor occlusal build-ups, and incisal abrasions. Type of Use (Select one or both, as applicable) 図 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 regarging 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}------------------------------------------------ # K223632 ## 510(k) SUMMARY ## Premier Dental's MultiMatch Universal Chameleon Restorative Composite #### Submitter Information Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, PA 19462 Contact Person: Jessica Huang, Director of Quality/Regulatory Phone: 610-239-6069 Facsimile: 610-239-6171 Date Prepared: November 29, 2022 Name of Device: Premier's MultiMatch Universal Chameleon Restorative Composite Common or Usual Name: Tooth Shade Resin Material Review Panel: Division of Dental and ENT Devices (DHT1B) Classification Name: Material, Tooth Shade, Resin Requlatory Class: 2 Product Code: EBF Regulation Number: 21 CFR §872.3690 #### Predicate Devices P1145 Dental Restorative (K162257) Trade Name: SimpliShade #### Device Description Premier's MultiMatch Universal Chameleon Restorative Composite is a light-cured, radiopaque, resin-based nanohybrid restorative composite. It is formulated for direct placement in any type of anterior and posterior cavity form. It is intended to be used with a dental bonding agent and can be sculpted prior to curing. Once light cured, the composite can be easily finished and polished to achieve a highly esthetic and durable restoration. Available in three chameleon shades, MultiMatch can be dispensed via a unit-dose capsule or syringe to provide a restoration with an excellent visual color match to the surrounding dentition. #### Intended Use / Indications for Use Premier's MultiMatch Universal Chameleon Restorative Composite has the following indications for use: Premier Multimatch Universal Chameleon Restorative Composite is a nano-hybrid dental restorative intended for direct placement in all cavity classes in anterior and posterior teeth. {4}------------------------------------------------ Additional indications include repair of enamel defects, repair of provisionals and repair of porcelain restorations, minor occlusal build-ups, core build-ups, and incisal abrasions. # Summary of Technological Characteristics Premier's MultiMatch is substantially equivalent to the predicate device, P1145 (K162257), known by Trade Name SimpliShade in terms of indications for use, composition, physical properties, and technological characteristics. Both the subject device and the predicate device are methacrylate-based resin system containing solid filler-particles to form a highly viscous paste which can be applied into a restoration preparation. The universal dental restoratives in the predicate and subject device are both formulated with methacrylate properties of resin and fillers to undergo light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. The composite is designed to have high mechanical strength and durability while maintaining excellent handling and esthetic characteristics. Premier's MultiMatch formulation has been modified from the predicates to improve physical properties of mechanical strength, color stability, and reduced polymerization shrinkage. | | P1145 SimpliShade (KAVO Kerr) | Premier's MultiMatch Universal<br>Chameleon Restorative Composite<br>(Subject Device) | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510K number | K162257 | To be assigned | | Trade Name | SimpliShade | MultiMatch | | Target Users | Licensed Dental Professionals | Licensed Dental Professionals | | Device<br>Description | P1145 is a light-cured, esthetic, resin<br>based nanohybrid dental restorative<br>designed for direct placement in both<br>anterior and posterior restorations. It<br>is<br>designed to be used after placement<br>of a dental adhesive. Once placed,<br>the composite can be easily sculpted<br>to the desired shape, and after curing,<br>can easily be finished and polished to<br>achieve a highly esthetic restoration. | Premier's Multimatch Universal<br>Chameleon Restorative Composite is<br>a light-cured, radiopaque, resin-based<br>nanohybrid restorative composite. It is<br>formulated for direct placement in any<br>type of anterior and posterior cavity<br>form. It is intended to be used with a<br>dental bonding agent and can be<br>sculpted prior to curing. Once light<br>cured, the composite can be easily<br>finished and polished to achieve a<br>highly esthetic and durable<br>restoration. Available in three<br>chameleon shades, MultiMatch can<br>be dispensed via a unit-dose capsule<br>or syringe to provide a restoration with<br>an excellent visual color match to the<br>surrounding dentition. | A table comparing the key features of the subject and predicate devices is provided below. {5}------------------------------------------------ | Classification<br>Name | Tooth Shade Resin Material | Tooth Shade Resin Material | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Class | 2 | 2 | | Product Code | EBF | EBF | | Intended Use | Dental Restorative | Dental Restorative | | Indications for<br>Use | P1145, a nano-hybrid dental<br>restorative, is indicated for direct<br>placement in all cavity classes in<br>anterior and posterior teeth. Additional<br>indication include: repair of enamel<br>defects, repair of provisionals, repair<br>of porcelain restorations, minor<br>occlusal build-ups and incisal<br>abrasions. | Premier MultiMatch Universal<br>Chameleon Restorative Composite is<br>a nano-hybrid dental restorative<br>intended for direct placement in all<br>cavity classes in anterior and<br>posterior teeth. Additional indications<br>include repair of enamel defects,<br>repair of provisionals and repair of<br>porcelain restorations, minor occlusal<br>build-ups, core build-ups, and incisal<br>abrasions | | Intended Patient<br>Population | Any age patient requiring restoration<br>or repair of teeth. | Any age patient requiring restoration<br>or repair of teeth. | | Curing<br>Mechanism | Photo-initiation | Photo-initiation | | Storage | Store at Room Temperature | Store at Room Temperature | | Composition | Bis-GMA<br>TEGDMA<br>Inorganic Filler<br>Photo- initiator | Bis-GMA<br>TEGDMA<br>Inorganic Filler<br>Photo- initiator | | Material<br>Compatibility | Meets Biocompatibility Requirements | Meets Biocompatibility Requirements | | Shelf Life | Min 24 months based on accelerated<br>data | Min 24 months based on accelerated<br>data | | Particle Size<br>Distribution | Nanohybrid:<br>nano and non-nano particle<br>sizes of filler ranging from 0.04 to 6<br>μm | Nanohybrid:<br>Proprietary formulation of<br>nano and non-nano particle<br>sizes of filler ranging from 0.7 to 5 μm | | Light Intensity<br>for Curing -<br>Halogen | 650-1000 mW/cm² | 650-1000 or Below 1000 mW/cm² | | Light Intensity<br>for Curing – LED | >1000 mW/cm² | 1100 - 1300 or above 1000 mW/cm² | | Wavelength for<br>Curing | 450-480 nm | 450-480 nm | | Depth of Cure | 2mm | 2mm | | Curing Time | Halogen - 40 seconds (dark shade)<br>Halogen – 20 seconds (light medium<br>and white shade)<br>LED - 20 seconds (dark shade)<br>LED - 10 seconds (light medium and<br>white shade | Minimum of 20 seconds | {6}------------------------------------------------ ## Non Clinical Performance Data Non-clinical performance data included testing for mechanical strength (flexural strength, compressive strength), water sorption and solubility, depth of cure, light sensitivity, radiopacity, polymerization shrinkage, volumetric wear, and color stability according to ISO 4049:2009. Working time and gloss were also performed. Biocompatibility testing was also conducted according to ISO 10993-1:2018. The data analyzed from the various tests substantiate that MultiMatch is safe and effective as the predicate P1145 (K162257). # Conclusions Premier's Multimatch Universal Chameleon Restorative Composite is as safe and effective as the identified predicate device. Premiers MultiMatch has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between Premier's Multimatch and its predicate devices raise no new issues of safety or effectiveness. Non-Clinical Performance data demonstrate that Premier's Multimatch is as safe and effective as Kerr's P1145 (K162257), known by Trade Name SimpliShade. Thus, Premier's Multimatch is substantially equivalent.