Nexus™ RMGI is a radiopaque resin-modified glass ionomer luting cement offered in a paste/paste/paste formulation that provides an option for tack light-curing of excess cement. This paster formalation that problems of a catalyst packaged in dual-barrel syringes. The base and catalyst are dispensed from the dual-barrel syringe through automix tips.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental cement (Nexus RMGI) and compares its performance characteristics to a predicate device (RelyX Luting Plus Automix). It does not describe an AI/ML device or a study involving human readers or AI assistance. Therefore, information regarding acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML devices cannot be extracted from this document.

However, I can extract the acceptance criteria and reported device performance for the Nexus RMGI dental cement based on the physical and chemical properties presented in the "Summary of Technological Characteristics" table.

Here's the table of acceptance criteria (represented by the predicate device's performance as a benchmark for substantial equivalence) and the reported device performance for Nexus RMGI:

1. A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (Predicate: RelyX Luting Plus Automix)	Reported Device Performance (Nexus RMGI)
Gel Time (Working Time) @ 22.5°C	3'20"	1'55"
Set Time @ 22.5°C	6'45"	3'15"
Set Time @ 37.0°C	4'45"	2'20"
Flexural Strength (MPa)	20.7	36.7
Compressive Strength (MPa)	103	154
Translucency (%)	16.1	39.1
Film Thickness (μm)	16	9
Consistency of mixed paste (cm)	3.2	2.9
Radiopacity (% Al)	150	217
Solubility (7 days, %)	0.94	0.28
Cumulative Fluoride Release (1 week, ppm)	41	25.7
Cumulative Fluoride Release (4 week, ppm)	81.9	48.1
Shear Bond Strength (Dentin, MPa)	15.6	20.2
Shear Bond Strength (Enamel, MPa)	10.5	16.2
Shear Bond Strength (Rexillium III, MPa)	12.0	26.3
Shear Bond Strength (Gold Alloy, MPa)	11.8	16.8
Shear Bond Strength (Zirconia, MPa)	13.8	17.5
Shear Bond Strength (Porcelain with HF etch, MPa)	14.3	23
Shear Bond Strength (Composite, MPa)	7.3	17.6
Shear Bond Strength (Lithium Disilicate, MPa)	14.9	17.7
Shear Bond Strength (Alumina, MPa)	13.1	14.9
Shear Bond Strength (Titanium, MPa)	13.4	25.2
Post (lbs)	34.8	53.9

2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing of material properties, not an AI/ML test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material property testing does not involve expert ground truth establishment in the way AI/ML studies do.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm. The performance described is for the dental cement itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance characteristics of the Nexus RMGI device is established through standardized laboratory bench testing methods (e.g., ISO 9917-2:2010 for flexural strength) and comparison to the predicate device's measured properties.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the non-clinical (bench) testing of a dental cement to establish substantial equivalence to a predicate device. It does not contain information relevant to AI/ML device performance or studies involving human-in-the-loop or standalone AI performance.

Summary

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1 < 123595

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a swooping line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is in black and white.

FEB 1 9 2013

510(k) Summary

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7472 - Facsimile Colleen Boswell - Contact Person

November 2012 Date Summary Prepared:

Trade Name Nexus RMG! ●
Common Name -- Luting Cement ◆
Classification Name -- Dental Cement, per 21 CFR 872.3275(b) .
Product Codes EMA ●

Devices for Which Substantial Equivalence is Claimed:

RelyX Luting Plus Automix, 3M ESPE, K111185 .

Device Description

Indications for Use

Nexus RMG/ is intended for use as a permanent dental cement. It is indicated for the following indirect restorations:

Cementation of metal-based inlays, onlays, crowns and bridges 1.
1. Cementation of resin inlays, onlays, crowns and bridges
Cementation of all ceramic inlays ന്
1. Cementation of high strength (zirconia based) all ceramic crowns and bridges
1. Cementation of metal, ceramic and fiber posts

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Summary of Technological Characteristics

Descriptive Information	Nexus RMGI	RelyX Luting Plus Automix (K111185)
Company	Kerr Corporation	3M ESPE
Indication for Use	Nexus RMGI is intended for use as a permanent dental cement. It is indicated for the following indirect restorations:Cementation of metal-based inlays, onlays, crowns and bridges Cementation of resin inlays, onlays, crowns and bridges Cementation of all ceramic inlays Cementation of high strength (zirconia based) all ceramic crowns and bridges Cementation of metal, ceramic and fiber posts	This device is intended for use as a dental cement. RelyXTM Luting Plus Automix (LEXUS-2) is indicated for Luting:Luting porcelain fused to metal crown and bridges to tooth structure, amalgam, composite or glass ionomer core build ups Luting mental inlays, onlays or crowns Luting pre-fabricated and cast post cementation Luting orthodontic appliances Luting crowns made with all-alumina or all zirconia cores such as Procera AllCeram
Gel Time (or Working Time) @ 22.5 ± 1.0°C	1'55"	3'20"
Set Time @ 22.5 ± 1.0°C	3'15"	6'45"
Set Time @ 37.0 ± 1.0°C	2'20"	4'45"
Flexural Strength (MPa) as per ISO 9917-2:2010	36.7	20.7
Compressive Strength (Mpa)	154	103
Filler Loading, wt.%	60.3	N/A
Translucency, %	39.1	16.1
Film Thickness, μm	9	16
Descriptive Information	Nexus RMGI	RelyX Luting Plus Automix (K111185)
Consistency of mixed paste, cm	2.9	3.2
Radiopacity, % Al	217	150
Solubility (7 days), %	0.28	0.94
Cumulative Fluoride Release, ppm
1 week	25.7	41
4 week	48.1	81.9
Shear Bond Strength to various substrates
Dentin, MPa	20.2	15.6
Enamel (Bovine), MPa	16.2	10.5
Rexillium III, MPa	26.3	12.0
Gold Alloy, MPa	16.8	11.8
Zirconia (Lava), MPa	17.5	13.8
Porcelain (Vitablocs) with HF etch, MPa	23	14.3
Composite (Premise Indirect), MPa	17.6	7.3
Lithium Disilicate , MPa	17.7	14.9
Alumina, MPa	14.9	13.1
Titanium, MPa	25.2	13.4
Post, lbs	53.9	34.8

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Non-Clinical Test Data

Biocompatibility studies were completed which demonstrate that the material is safe for its Blocomputiblicy outdite The following tests: ISO L929 MEM Elution Test, intended abor Nexts Arrenm and Escherichia Coli Reverse Mutation Assay, ISO Intramuscular Implantation Test, ISO Kligman Maximization Test and ISO Oral Irritation Test.

The 510(k) submission also includes data from bench testing used to evaluate performance characteristics of Nexus RMG/ as compared to the predicate device, RelyX Luting Plus Automix currently marketed by 3M ESPE. The characteristics evaluated include Work Time, Set Times, Flexural Strength, Compressive Strength, Filler Loading, Translucency, Film Thickness, Consistency of Mixed Paste, Radiopacity, Solubility, Fluoride Release and Bond Strength.

Clinical Test Data

Clinical testing has not been conducted on this product.

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Conclusion

Based upon the biocompatibility tests and bench testing, the clinical performance of Nexus
Based of the biocompany of the bit interently Based upon the blocompanisms, testo and benefield be news in the RelyX Luting Plus Automix.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 19, 2013

Kerr Corporation C/O Ms. Colleen Boswell Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue ORANGE CA 92867

Re: K123595

Trade/Device Name: Nexus RMGI Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA Dated: November 19, 2012 Received: November 21, 2012

Dear Ms. Boswell:

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/7 description: The image shows the name "Kwame O. Ulmer" with the letters "FDA" in the background. The letters "FDA" are stylized with a line pattern. The name is written in a bold, sans-serif font.

Anthony D. Watson, B.S., M.S., M.B.A. 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):

માટિકલ ક

Device Name: Nexus RMGI

Indications for Use:

Nexus RMGI is intended for use as a permanent dental cement. It is indicated for the following indirect restorations:

1. Cementation of metal-based inlays, onlays, crowns and bridges
1. Cementation of resin inlays, onlays, crowns and bridges
1. Cementation of all ceramic inlays
1. Cementation of high strength (zirconia based) all ceramic crowns and bridges
1. Cementation of metal, ceramic and fiber posts

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner 2013.02.19 15:38:46 ODS BA

05'00': 8 9

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number;

Kerr Corporation - RMGI - 510(k) Submission

Section 004 - Page 2 of 2

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.