(121 days)
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.
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.
The provided document is a 510(k) summary for a dental cement (Nexus Universal Self-Cure), which is a device used for restorative dentistry. The document focuses on demonstrating substantial equivalence to a predicate device (Suglue-10) through technological characteristics, performance testing, and biocompatibility.
It does not describe a study involving an AI/Medical Device that processes images or requires human expert adjudication for ground truth, Multi-Reader Multi-Case (MRMC) studies, or the performance of an algorithm. The context of the original request seems to be geared towards diagnostic or assistive AI devices, whereas this document pertains to a physical dental material.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set, training set sample size, how ground truth was established) are not applicable to this type of medical device submission.
However, I can extract the relevant information regarding acceptance criteria and performance as presented for this dental material.
Acceptance Criteria and Device Performance (Dental Cement - Nexus Universal Self-Cure)
The acceptance criteria here are established by comparing the performance of the proposed device (Nexus Universal Self-Cure) to a legally marketed predicate device (Suglue-10) and relevant ISO standards. Substantial equivalence is demonstrated by showing that the new device performs "similar to" or "at least as good as" the predicate, or meets established standard thresholds.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" values independently but presents a comparative table (Table 5.1) where the predicate's performance serves as a de facto benchmark for the subject device to achieve substantial equivalence. The "Subject" values are the reported device performance. ISO standards provide the basis for the criteria.
| Element | Acceptance Criteria (typically from ISO standards and/or predicate performance) | Reported Device Performance (Nexus Universal Self-Cure) |
|---|---|---|
| Film Thickness | < 50 µm (ISO 16056:2017) | < 50 µm |
| Flexural Strength | > 100 MPa (ISO 16056:2017) | > 110 MPa |
| Radiopacity | Average: 187 (Predicate) | Average: > 230 |
| Working Time | > 1 min (Predicate) | > 1 min |
| Setting Time | > 10 min (Predicate) | < 8 min |
| Shear Bond Strength (Dark Cure) | Average: 16.82 MPa (Predicate) | Average: > 20 MPa |
| Shear Bond Strength (Light Cure) | Average: 23.22 MPa (Predicate) | Average: > 25 MPa |
| Biocompatibility | Biocompatible per ISO 10993 | Biocompatible per ISO 10993 |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (number of tests/specimens) used for each performance test (e.g., film thickness, flexural strength, shear bond strength). It refers to "various tests" and "the data analyzed from the various tests."
- Data Provenance: The tests are non-clinical performance tests conducted by the manufacturer, Kerr Corporation, in a laboratory setting. The country of origin of the data is not explicitly stated but is implied to be within the US, given the submission to the FDA. The tests are retrospective in the sense that they were completed prior to the 510(k) submission. They are laboratory bench tests, not clinical retrospective/prospective studies on patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This is a physical dental material, and the "ground truth" is established through standardized laboratory testing (bench testing) against ISO standards and comparison to a predicate device, not through human expert interpretation of images or clinical outcomes that require expert consensus or adjudication.
4. Adjudication Method for the Test Set:
- Not Applicable. See point 3. Testing involves objective measurements of material properties, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-assisted diagnostic or imaging device. No human-in-the-loop study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical dental cement; there is no algorithm. The "standalone" performance refers to the intrinsic material properties measured in lab tests.
7. The Type of Ground Truth Used:
- Bench Test Results / ISO Standards / Predicate Device Performance: The "ground truth" for the performance evaluation is derived from the results of standardized non-clinical (bench) tests according to ISO standards (e.g., ISO 1641, ISO 1041, ISO 7405, ISO 29022, ISO 14971, ISO/TS 16506, ISO 10993-1, ISO 11405). The measured properties of the new device are directly compared to the established properties of the predicate device and the thresholds set by these international standards.
8. The Sample Size for the Training Set:
- Not Applicable. This device is a physical product, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. This device is a physical product, not an AI model that requires a training set or corresponding ground truth for training.
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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.
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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 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
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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)
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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:
-
- 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 |
-
- 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 |
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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.
-
- 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:
- Summary of Non-Clinical Performance Data:
-
· 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
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- · 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.
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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 |
| ClassificationName | Dental cement other that zincoxide-eugenol | Same |
| FDA Class | II, 21 CFR 872.3275 | Same |
| Product Code | EMA | Same |
| DeviceDescription | Suglue-10 is a dual-curing resincement supplied in an automixsyringe. It is used for theadhesive cementation of indirectrestorations and available invarious shades. Suglue-10 isused in combination withScotchbond™UniversalAdhesive.The adhesive can be used eitheras a "Total Etch" or "Self-Etch"procedure. The additionaletching of the tooth structurewith Scotchbond™Universal | Nexus Universal Self-Cure is a two-component, automix, dual-curebonded resin cement that is in thepermanent cement category of dentalrestorative materials. The NexusUniversal Self-Cure is packaged intoa syringe and extruded out with anautomix tip prior to use.The cement is designed to simplifycementation of restorative substratesuch that 1) the product can be usedwith all OptiBond products withoutthe need to light-cure theadhesive/bonding agent on the toothstructure, 2) eliminate the need for |
| Element | PredicateSuglue-10 | SubjectNexus Universal Self-Cure |
| Intended Use | Adhesive cementSuglue-10 is indicated for: | Adhesive cementNexus 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.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.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(Delivery System) | Auto-mix syringe | Auto-mix syringe |
| CuringMechanism | Photo-initiation and chemical cure (self-cure) | Same |
| Resin Type | Methacrylate Resin | Same |
| Film thickness(ISO 16056:2017) | < 50 μm | < 50 μm |
| Element | PredicateSuglue-10 | SubjectNexus Universal Self-Cure |
| Flexural Strength(ISO 16056:2017) | > 100 MPa | > 110 MPa |
| Radiopacity(ISO 16056:2017) | Average: 187 | Average: > 230 |
| Working time | > 1 min | > 1 min |
| Setting Time | > 10 min | < 8 min |
| Shear BondStrength | (dark cure) Average: 16.82 MPa(light cure) Average: 23.22 MPa*Tested with manufacturerrecommended bonding agent permanufacturer instructions foruse. | (dark cure) Average: > 20 MPa(light cure) Average: > 25 MPa*Tested with recommended bondingagent: OptiBond™ Universal |
| SubstrateMaterialCompatibility | Ceramic, composite, metal | ceramic, porcelain, resin, metal-based, zirconia, and CAD/CAMblock materials |
| Biocompatibility | Biocompatible per ISO 10993 | Same |
Table 5.1: Comparison of Subject and Predicate Devices
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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.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.