Nexus Universal/Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.

Adhesive application on the preparation is required for veneer cementation using Nexus Universal Chroma.

Device Description

Nexus Universal / Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.

Adhesive application on the preparation is required for veneer cementation using Nexus Universal and Nexus Universal Chroma.

Nexus Universal and Nexus Universal Chroma are offered in paste/paste formulations for use as self-etch, self-adhesive resin cements or as bonded resin cements. These cements are considered permanent and not temporary.

The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration and/or tooth preparation.

Nexus Universal and Nexus Universal Chroma are offered in multiple shades. The difference between Nexus Universal and Nexus Universal Chroma is that Nexus Universal Chroma offers a gel-state color indicator, which visually displays the optimal time to remove the excess cement.

AI/ML Overview

The provided document describes the acceptance criteria and a study to demonstrate substantial equivalence for the dental cement "Nexus Universal" and "Nexus Universal Chroma."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document uses the predicate device (Maxcem 2, K073209) as a benchmark for acceptance criteria. The Nexus Universal/Chroma is considered substantially equivalent if its performance is comparable or improved.

Element	Acceptance Criteria (Predicate: Maxcem 2)	Reported Device Performance (Nexus Universal/Chroma)
Gel/Set Time (fresh ambient/fresh oral)	≥ 2'00" / ≤ 3'30"	≥ 2'00" / ≤ 3'30"
Bond Strength to Dentin	20.35 MPa	23.05 MPa (Improved)
Bonding strength for Post Cementation	59.68 lbs	62.34 lbs (Improved)
Radiopacity, % aluminum	280%	283% (Improved)
Film Thickness (μm)	22 μm	24 μm
Diametral Strength, Mpa (Dual-Cure mode)	54.8 MPa	58.1 MPa (Improved)
Consistency	3.00 cm	3.39 cm
Maximum Temperature During Self Curing	N/A (Predicate did not report)	26.89°C
Water sorption	N/A (Predicate did not report)	33.5 µg/mm³
Color at set time (for Chroma version)	N/A (Predicate did not have a color indicator)	Pass (Visually displays optimal time to remove excess)
Biocompatibility	Meets requirements	Meets requirements
Shelf Life	18 months based on real-time data	18 months based on accelerated data

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., bond strength, film thickness). It globally refers to the data as "Non-Clinical Performance Data" and "internal performance testing."

Sample Size: Not explicitly stated for individual tests.
Data Provenance: The data is described as "internal performance testing." This implies the tests were conducted by the manufacturer, Sybron Dental Specialties. The country of origin is not specified but given the submitter information, it is likely the US. The data is retrospective as it refers to completed tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests are non-clinical (laboratory-based) and don't involve human expert assessment for ground truth in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" for these tests would be the measured physical and chemical properties of the material.

4. Adjudication method for the test set

This information is not applicable as the study is based on non-clinical laboratory tests, not subjective expert assessment requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. This device is a dental cement, and the evaluation is based on material properties and non-clinical performance, not on AI-assisted human reading of medical cases.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a dental cement, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical performance tests would be the measured physical, chemical, and mechanical properties of the dental cement, determined through standardized laboratory testing methods (e.g., ISO standards, FDA guidance). For example, a bond strength measurement has a direct numerical ground truth.

8. The sample size for the training set

This information is not applicable. The device is a physical material (dental cement), not an AI model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2015

Sybron Dental Specialties Ms. Courtney Clark Regulatory Affairs Manager 1717 W. Collins Avenue Orange, CA 92867

Re: K151332

Trade/Device Name: Nexus Universal, Nexus Universal Chroma Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: May 18, 2015 Received: May 19, 2015

Dear Ms. Clark:

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.

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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 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.

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 yours,

Image /page/1/Picture/8 description: The image shows a signature with the name "Tina Kiang -S" written in a simple, sans-serif font. The first name, "Tina," is positioned above the last name, "Kiang," with a hyphen and the letter "S" following the last name. To the left of the name is a stylized, looping signature mark that appears to be a series of connected curves and lines.

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) K151332 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Device Name

Nexus Universal/ Nexus Universal Chroma

Indications for Use (Describe)

Adhesive application on the preparation is required for veneer cementation using Nexus Universal Chroma.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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."

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SECTION 5. 510(k) SUMMARY for Nexus Universal / Nexus Universal Chroma

Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized, bold, blue font, with a curved line above the letters. Below the letters, the words "Sybron Dental Specialties" are written in a smaller, less bold font, also in blue.

Nexus Universal /Nexus Universal Chroma

Submitter Information: 1. Sybron Dental Specialties
1717 W. Collins Ave. Orange CA, 92687

Contact Person:	Courtney Clark
Telephone Number:	714-516-7426
Fax Number:	714-516-7472

Date Prepared: May 18, 2015

1. Device Name:
- Proprietary Name: Nexus Universal and Nexus Universal Chroma .
- . Classification Name: Dental Cement w/out Zinc-Oxide Eugenol

Cement, Dental

872.3275 CFR Number: ●
Device Class: II .
Product Code: EMA .
1. Predicate Device:

The proposed Nexus Universal and Nexus Universal Chroma are substantially equivalent to the legally marketed predicate device. Maxcem 2 (K073209), cleared on January 29, 2008, product codes MZW, EMA.

1. Description of Device:
  Nexus Universal / Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.

Adhesive application on the preparation is required for veneer cementation using Nexus Universal and Nexus Universal Chroma.

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Accessories Used with NexusUniversal / Nexus Universal Chroma	Manufacturer of Accessory
Dual barrel syringe	Sulzer Mixpac AGRuetistrasse 7Haag Sankt gallen, Switzerland 9469
Curved dispensing tips	Sulzer Mixpac AGRuetistrasse 7Haag Sankt gallen, Switzerland 9469
Auto-mix tips	Sulzer Mixpac AGRuetistrasse 7Haag Sankt gallen, Switzerland 9469

న. Statement of Indications for Use:

Adhesive application on the preparation is required for veneer cementation using Nexus Universal and Nexus Universal Chroma.

6. Description of Substantial Equivalence:

Technological Characteristics

Nexus Universal and Nexus Universal Chroma, like their predicate Maxcem 2 (K073209), are self-adhesive paste/paste dual-cure permanent resin cements. Thev provide a simplified one-step cementation procedure by combining the etching, priming, bonding and cementing steps into a single step. This is achieved by incorporating adhesive monomers along with an acid tolerant redox initiator system into a traditional resin cement.

There are two curing mechanisms associated with the proposed Nexus Universal and Nexus Universal Chroma self-adhesive resin cements: self-curing (also referred to as dark-curing) mechanism by a redox initiator system and light-curing by a photoinitiator.

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The proposed Nexus Universal and Nexus Universal Chroma offer the following changes over the predicate, Maxcem 2 (K073209):

1. A gel-state color indicator (Nexus Universal Chroma only) provides clinicians with a visual cue indicating the optimal timing to remove the gelled excess cement
1. Increased bond strength to dentin
1. Increased bond compatibility with adhesive even in self-cure mode (also referred to as dark-cure mode)

The proposed Nexus Universal Chroma has a gel-state indicator that is a redox color indicator that has an initial pink color for the mixed paste before gelation. The pink color will fade away once the mixed paste reaches the gel state, the ideal timing for removing excess cement. For both the Nexus Universal and Nexus Universal Chroma, the increased bond strength to dentin and the increased bond compatibility with the adhesive in self-cure mode is achieved by modifying the adhesive property of the resin matrix and wetting ability of the pastes along the acid tolerant redox initiator system used in the proposed.

Non-Clinical Performance Data

Non-clinical performance data included testing for bond strength to various substrates, radiopacity, film thickness, diametral strength, consistency, amount of heat generated during setting, water sorption, dark-cure bond compatibility, and gel-state indicator color transition.

Gel/set time testing and biocompatibility testing were also performed. The data analyzed from the various tests substantiate that the proposed Nexus Universal and Nexus Universal Chroma are substantially equivalent to the predicate, Maxcem 2 (K073209). The following standards were utilized for the non-clinical performance testing of the proposed:

ISO 10993-1: 2009 Biological evaluation of medical devices
ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for ● Genotoxicity, Carcinogenicity, and Reproductive Toxicity
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in ● Vitro Cytotoxicity
ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation
ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-11: 2006 Biological Evaluation of Medical Devices- Part 11: Tests for System Toxicity
. ISO 4049: 2009 Dentistry - Polymer-Based Restorative Materials

Additional testing was performed as recommended by the following guidance document:

. FDA "Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification"

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Table 5.1: Predicate and Proposed Device Comparison Table

Element	Predicate Device- Maxcem 2	Nexus Universal/NexusUniversal Chroma, DentalCement
510(k)	Maxcem 2 (K073209)	To be assigned
Trade Name	Maxcem 2, Dental Cement	Nexus Universal and NexusUniversal Chroma, Dental Cement
Target Users	Licensed dental professionals	Licensed dental professionals
Indications for Use	Maxcem 2 is intended forcementation of indirect restorationsincluding ceramic, resin and metal-based inlays, onlays, crowns, bridges,posts, and veneers.* Additionalindications include core-buildupmaterial, pit and fissure sealant, andcementation of crown restorations toimplants.*Adhesive application on the prep isrequired for veneer cementationusing Maxcem 2.	Nexus Universal/Nexus UniversalChroma is indicated forcementation of all indirectrestorations including ceramic,resin, and metal-basedinlays/onlays, crowns, bridges,posts, and veneers. Additionalindications include core build-upsand cementation of crowns toimplants.Adhesive application on thepreparation is required for veneercementation using NexusUniversal and Nexus UniversalChroma.
Common Name	Dental Cement	Dental Cement
Classification Name	Cement, Dental, per 21 CFR §872.3275(b)	Cement, Dental, per 21 CFR §872.3275(b)
Class	II	II
Product Code	MZW/EMA	MZW/EMA
Storage	Ambient Temperature	Ambient Temperature
Curing Mechanism	Photo initiation or self-cure	Photo initiation or self-cure
Material Compatibility	Biocompatibility meets requirements	Biocompatibility meetsrequirements
Shelf Life	18 months based on real time data	18 months based on accelerateddata
Gel/Set Time(fresh ambient/ freshoral)	≥ 2'00" / ≤ 3'30"	≥ 2'00" / ≤ 3'30"
Bond Strength toDentin	20.35 MPa	23.05 MPa
Bonding strength forPost Cementation	59.68 lbs	62.34 lbs
Radiopacity, %aluminum	280%	283%
Film Thickness (μm)	22 μm	24 μm
Diametral Strength,Mpa (Dual-Curemode)	54.8 MPa	58.1 MPa
Consistency	3.00 cm	3.39 cm
MaximumTemperature DuringSelf Curing	N/A	26.89°C
Water sorption	N/A	33.5 µg/mm³
Color indicator version(Nexus UniversalChroma):	N/A
Color at set time	N/A	Pass

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Clinical Performance Data

Clinical performance testing has not been performed for the proposed devices.

Conclusion as to Substantial Equivalence

The slight modifications to the formula of the predicate, Maxcem 2 (K073209), to increase bond strength and bond compatibility with the adhesive in self-cure mode, and add the gel-state color indicator (Nexus Universal Chroma only) shall not affect the safety or efficacy of the proposed devices based on internal performance testing and biocompatibility testing. Nexus Universal and Nexus Universal Chroma are substantially equivalent to the predicate, Maxcem 2 (K073209), based on formulation, performance and testing comparisons.

Regulation Number and Section

§ 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.