Nexus Universal Self-Cure

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 11, 2019 Kerr Corporation % Ardrena Jackson Sr. Regulatory Affairs Specialist Sybron Dental Specialties 1717 W. Collins Ave. Orange, California 92867 Re: K191548 Trade/Device Name: Nexus Universal Self-Cure Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: July 15, 2019 Received: July 16, 2019 Dear Ardrena Jackson: 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 medical devices and radiation-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. for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### SECTION 4. INDICATIONS FOR USE STATEMENT DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K 191548 Device Name Nexus Universal Self-Cure Indications for Use (Describe) Nexus Universal Self-Cure is a bonded resin cementation of indirect restoration of indirect restorations including veneers, inlays, onlays, crowns, bridges, posts, and the cementations to implant abutments. Nexus Universal Self-Cure can be used for the cementation of ceramic, porcelain, resin, metal-based, zirconia, and CAD/CAM block materials. Nexus Universal Self-Cure can also be used for the adhesive bonding of amalgam restorations and as a core build-up material. 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." Page 1 of 1 PSC Publishing Services (301) 443-6740 FORM FDA 3881 (7/17) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ ## 510(k) SUMMARY Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized, connected font, with a curved line above them. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, sans-serif font. # 510(k) SUMMARY for K191548- NEXUS UNIVERSAL SELF-CURE In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21CFR §807.92, the following summary of information is provided: - 1. Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687 | Contact Person: | Ardrena Jackson | |--------------------|------------------| | Telephone Number: | 714-516-7491 | | Fax Number: | 909-962-5694 | | Alternate Contact: | Jennifer Evans | | Telephone Number: | 714-516-7795 | | Fax Number: | 909-962-5694 | | Date Prepared: | October 11, 2019 | - 2. Device Name: | Classification Name | Dental Cement | |---------------------|---------------------------| | FDA CDRH Panel | Dental | | Product Code | EMA | | Regulation Number | 872.3275 | | Class # | II | | Trade Name | Nexus Universal Self-Cure | {4}------------------------------------------------ - 3. Primary Predicate: The device Nexus Universal Self-Cure is substantially equivalent to the predicate Suglue-10, (K110508), Trade name RelyX ™Ultimate (K110508), product code EMA, cleared by FDA on June 3, 2011. #### 4. Description of Device: Nexus Universal Self-Cure is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. § 872.3275) because it is a device composed of various materials other than zinc oxide-eugenol. Nexus Universal Self-Cure, manufactured by Kerr Corporation, is a two-component, auto-mixing, dual-cure bonded resin cement consisting of catalyst and base paste at a 4:1 ratio, packaged into a syringe extruded out with an automix tip prior to use. The cement is designed to simplify cementation of restorative substrate such that product can be used with adhesive/bonding agents without the need to light-cure the adhesive/bonding agent on the tooth structure and to eliminate the need for primer treatment on the substrate prior to cement applications. Nexus Universal Self-Cure will be available in various shades. #### 5. Indications for Use Nexus Universal Self-Cure is a bonded resin cement indicated for the cementation of indirect restorations including veneers, inlays, onlays, crowns, bridges, posts, and the cementation of crown restorations to implant abutments. Nexus Universal Self-Cure can be used for the cementation of ceramic, porcelain, resin, metal-based, zirconia, and CAD/CAM block materials. Nexus Universal Self-Cure can also be used for the adhesive bonding of amalgam restorations and as a core build-up material. - 6. Summary of Non-Clinical Performance Data: Non-clinical performance data includes testing for shear bond strength to various substrates. The data analyzed from the various tests substantiate that Nexus Universal Self-Cure performs similar to the predicate Suglue-10 (K110508). The following standards were utilized for non-clinical performance testing of Nexus Universal Self-Cure: - · EN ISO 1641: 2009 Dentistry Medical devices for dentistry Materials - · EN ISO 1041:2008 Information supplied by the manufacturer of medical devices. - · ISO 7405:2008 Evaluation of medical devices used in dentistry - · ISO 29022:2013 Dentistry Adhesive Notched Edge Sheer Bond Strength Test* - · ISO 14971:2007 Risk Management - · ISO/TS 16506:2017 Polymer-Based Luting Materials Containing Adhesive Components - · ISO 10993-1: Biological evaluation of medical devices Evaluation and testing within a risk management {5}------------------------------------------------ - · ISO 11405:2015* Dentistry Testing of Adhesion to Tooth Structure * With modifications to teeth selection, storage, and teeth surface preparation. #### 7. Description of Substantial Equivalence: Kerr Corporations, Nexus Universal Self-Cure is substantially equivalent (as defined in 21 U.S.C. § 360c(i)) for all regulatory purposes to the predicate device Suglue-10 (K110508) manufactured by 3M ESPE. For purposes relevant to this regulatory filing, and as discussed in the previous subsections, technological characteristics, composition and performance testing indicate the substantial equivalence of the Nexus Universal Self-Cure to the predicate device Suglue-10. ### a) Technological Characteristics: The technological principle for both the subject Nexus™ Unviersal and predicate Suglue-10 is the product application as a permanent adhesive (bonded) resin dental cement. A comparison between the technological characteristics of Nexus Universal Self-Cure and that of legally marketed predicated device, Sueglue-10 (K11508) is summarized in Table 5.1, and demonstrates that the design, technology and composition of the Nexus Universal Self-Cure are substantially equivalent. The cement has the capability to polymerize (curing/setting) the adhesive layer on the tooth structure via chemical reaction upon interaction (no light curing of adhesive layer needed). Both the subject device and its predicate consist of base paste and catalyst paste. Both products are packaged in dual barrel syringes, are extruded out via a designated auto-mix syringe tip for ease of delivery, eliminating the need to hand-mixed the base paste and catalyst paste. Both Nexus Universal Self-Cure and the predicate Suglue-10 can be cured/polymerized by application of light from dental curing light (light curing mode). ### b) Performance Testing: The performance data compares the shear bonding strength (to dentin and various restorative substrates), film thickness, sensitivity to ambient light, flexural strength, water sorption, color stability, radiopacity, gel-time (work-time), and set-time of Nexus™ Universal to the predicate Suglue-10. Biocompatibility testing was performed on Nexus Universal per ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process included cytotoxicity, irritation or intracutaneous reactivity, and implantation evaluation. The performance data demonstrates biocompatibility of the device. ### c) Clinical Performance Data: Clinical performance testing has not been completed for this product. {6}------------------------------------------------ ### d) Substantial Equivalence Comparison: The following table (Table 5.1) compares Nexus Universal Self-Cure to the predicate device, Suglue-10 (K110508). Based on the biocompatibility testing, bench testing and performance testing there is sufficient evidence to demonstrate substantial equivalence of the proposed Nexus Universal Self-Cure device to the predicate device Suglue-10 (K110508). | Element | Predicate | Subject | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Suglue-10 | Nexus Universal Self-Cure | | 510(k) | K110508 | K191548 | | Manufacturer | 3M ESPE | Kerr Corporation | | Trade Name | Relyx Ultiamte | Nexus Universal Self-Cure | | Target Users | Licensed Dental Professionals | Licensed Dental Professionals | | Common Name | Adhesive Resin Cement | Same | | Classification<br>Name | Dental cement other that zinc<br>oxide-eugenol | Same | | FDA Class | II, 21 CFR 872.3275 | Same | | Product Code | EMA | Same | | Device<br>Description | Suglue-10 is a dual-curing resin<br>cement supplied in an automix<br>syringe. It is used for the<br>adhesive cementation of indirect<br>restorations and available in<br>various shades. Suglue-10 is<br>used in combination with<br>Scotchbond™Universal<br>Adhesive.<br>The adhesive can be used either<br>as a "Total Etch" or "Self-Etch"<br>procedure. The additional<br>etching of the tooth structure<br>with Scotchbond™Universal | Nexus Universal Self-Cure is a two-<br>component, automix, dual-cure<br>bonded resin cement that is in the<br>permanent cement category of dental<br>restorative materials. The Nexus<br>Universal Self-Cure is packaged into<br>a syringe and extruded out with an<br>automix tip prior to use.<br>The cement is designed to simplify<br>cementation of restorative substrate<br>such that 1) the product can be used<br>with all OptiBond products without<br>the need to light-cure the<br>adhesive/bonding agent on the tooth<br>structure, 2) eliminate the need for | | Element | Predicate<br>Suglue-10 | Subject<br>Nexus Universal Self-Cure | | Intended Use | Adhesive cement<br>Suglue-10 is indicated for: | Adhesive cement<br>Nexus Universal Self-Cure indicated for: | | Indications for Use | Final cementing of ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis) Final cementing of posts and screws Final cementation of all-ceramic, or composite veneers Final cementation of all-ceramic, composite, or metal restorations on implant abutments | The cementation of indirect restorations including veneers, inlays, onlays, crowns, bridges, posts, and The cementation of crown restorations to implant abutments. The cementation of ceramic, porcelain, resin, metal-based, zirconia, and CAD/CAM block materials The adhesive bonding of amalgam restorations and as a core build-up material. | | | Etchant increases the adhesive strength even further.<br><br>Suglue-10 contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 43% volume; the grain size (D 90%) is about 13 μm. The mixing ratio, based on volume, is 1 part base paste: 1 part catalyst. | primer treatment on the substrate prior to cement applications.<br><br>Nexus Universal Self-Cure contains bi-functional methacrylate. The proportion of inorganic fillers is above 40% volume. The mixing ratio, based on volume, is 4 parts base paste: 1 part catalyst. | | Packaging Type<br>(Delivery System) | Auto-mix syringe | Auto-mix syringe | | Curing<br>Mechanism | Photo-initiation and chemical cure (self-cure) | Same | | Resin Type | Methacrylate Resin | Same | | Film thickness<br>(ISO 16056:2017) | < 50 μm | < 50 μm | | Element | Predicate<br>Suglue-10 | Subject<br>Nexus Universal Self-Cure | | Flexural Strength<br>(ISO 16056:2017) | > 100 MPa | > 110 MPa | | Radiopacity<br>(ISO 16056:2017) | Average: 187 | Average: > 230 | | Working time | > 1 min | > 1 min | | Setting Time | > 10 min | < 8 min | | Shear Bond<br>Strength | (dark cure) Average: 16.82 MPa<br>(light cure) Average: 23.22 MPa<br>*Tested with manufacturer<br>recommended bonding agent per<br>manufacturer instructions for<br>use. | (dark cure) Average: > 20 MPa<br>(light cure) Average: > 25 MPa<br>*Tested with recommended bonding<br>agent: OptiBond™ Universal | | Substrate<br>Material<br>Compatibility | Ceramic, composite, metal | ceramic, porcelain, resin, metal-based, zirconia, and CAD/CAM<br>block materials | | Biocompatibility | Biocompatible per ISO 10993 | Same | ## Table 5.1: Comparison of Subject and Predicate Devices {7}------------------------------------------------ {8}------------------------------------------------ #### Conclusion of Substantial Equivalence. e) Based on technological characteristics, intended use, biocompatibility testing and performance testing, the subject device Nexus Universal Self-Cure is substantially equivalent to the predicate device Suglue-10 (K110508). Compared to Suglue-10, Nexus Universal Self-Cure can be used without a primer and has a formulation substantially equivalent to Suglue-10 (K110508), which is marketed to be used with a primer.