Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
Luting metal 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

Device Description

3M™ ESPE™ RelyX™ Luting Plus Automix (Lexus-2) is a radiopaque, fluoride-releasing, resinmodified glass ionomer luting cement. It is self-curing with an option for tack light curing of excess cement. RelyX Luting Plus Automix (Lexus-2) consists of a base (Paste A) and catalyst (Paste B) packaged in an automix (dual barrel) syringe. The dual barrel syringe dispenses paste A and Paste B. The cement is available in a white shade.

AI/ML Overview

The provided text describes the acceptance criteria and a study demonstrating that the device, RelyX™ Luting Plus Automix, meets these criteria.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by comparing the performance of the new device (RelyX™ Luting Plus Automix, referred to as Lexus 2) against a legally marketed predicate device (3M™ ESPE™ RelyX™ Luting Plus Cement, K022476). The reported device performance is indicated by "pass" for all tested properties, signifying that Lexus 2 met or exceeded the design specifications, which are implicitly acceptable as they are compared to a predicate device.

Properties	Method	Lexus 2 Design Specification	Lexus2 Ave and Predicate (K022476) Performance
Flexural strength (FS) (MPa)	ISO 9917-2	≥ 10 MPa	pass
Radio-opacity (mm of Al)	ISO 9917-2	≥1.0mm of Al	pass
Adhesion to dentin (MPa)	3M ESPE internal	≥2 MPa	pass
Adhesion to enamel (MPa)	3M ESPE internal	≥2 MPa	pass
Adhesion to Metal (MPa)	3M ESPE internal	≥2 MPa	pass
Adhesion to Lava™ (MPa) zirconia	3M ESPE internal	≥2 MPa	pass
Adhesion to composites	3M ESPE internal	≥2 MPa	pass
Adhesion to amalgam	3M ESPE internal	≥2MPa	pass
Adhesion to Titanium (MPa)	3M ESPE internal	≥2 MPa	pass
Adhesion to Lithium disilicate (MPa)	3M ESPE internal	≥2 MPa	pass
Fluoride release (µg F/g) at 90 days	3M ESPE internal	≥500	pass
Film thickness (microns)	ISO 9917-2	≤ 25	pass
Work time (s)	3M ESPE internal	≥ 90s	pass
Set time (s)	3M ESPE internal	<480s	pass

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

The document does not explicitly state the specific sample sizes used for each individual bench test. It mentions that the data is obtained from "Bench Test Data Comparison," and the methods used for certain tests are "ISO 9917-2" and "3M ESPE internal" methods.

The data provenance is from internal testing conducted by 3M ESPE. There is no mention of country of origin for the data or whether it was retrospective or prospective, but it implies a controlled laboratory environment designed to compare the new device to the predicate.

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

Not applicable. This study concerns the physical and chemical properties of a dental cement, evaluated through standardized bench tests and internal laboratory methods, rather than expert interpretation of medical images or patient data. Therefore, there is no "ground truth" established by experts in the context of medical diagnosis.

4. Adjudication method for the test set

Not applicable. This study does not involve human interpretation or subjective assessment that would require an adjudication method. The evaluations are based on predefined quantifiable metrics and established testing protocols.

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. This is not a study involving human readers or AI assistance. It is a bench test comparison of the physical and chemical properties of a dental cement.

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

Not applicable. This is not an algorithm or AI-based device. It is a dental cement, and its performance is assessed through laboratory bench tests.

7. The type of ground truth used

The "ground truth" in this context is established by:

International Standards: ISO 9917-2 for Flexural Strength, Radio-opacity, and Film Thickness. These standards define the methods and potentially acceptable ranges for these properties.
Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance of the legally marketed predicate device (RelyX™ Luting Plus Cement, K022476). The new device is considered substantially equivalent if its performance (as measured by design specifications and actual test results) is comparable to or better than the predicate's and meets the specified criteria.
Internal 3M ESPE Specifications: For properties like adhesion, fluoride release, work time, and set time, "3M ESPE internal" methods and "Design Specifications" are used, implying established internal criteria and methods by the manufacturer.

8. The sample size for the training set

Not applicable. This is a bench test study for a physical product, not a machine learning model, so there is no training set in the AI/ML sense.

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

Not applicable, as there is no training set.

Summary

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3M ESPE Dental Products

Image /page/0/Picture/1 description: The image shows the logo for 3M ESPE. The logo is in black and white, with the words "3M ESPE" in a bold, sans-serif font. The letters are evenly spaced and the logo is well-defined. The logo is simple and recognizable.

3M Center St. Paul, MN 55144-1000 651 733 1110

KIIII85

MAY - 5 2011

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

510(k) Submitter	3M Company3M ESPE Dental Products3M Center, Bldg. 260-2A-11St. Paul, MN 55144-1000 USA
Contact person	Bernardo M. Medellin J.D.Regulatory Affairs SpecialistPhone: (651) 733-5718Fax: (651) 737-9665bmmedellin1@mmm.com
Date Summary was Prepared	March 31th, 2011
Trade Name	RelyX TM Luting Plus AutomixResin Modified Glass Ionomer Cement
Common Name(s)	Dental Cement, polymer based
Recommended Classification	Resin Modified Glass Ionomer Cement(21 CFR 872.3275, Product Code: EMA)
Predicate Devices:	3M TM ESPE TM RelyX TM Luting Plus Cement (K022476)

Description of Device:

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Indications for Use:

This device is intended for use as a dental cement. RelyX™ Luting Plus Automix (Lexus-2) is indicated for Luting:

Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or . glass ionomer core build ups;
. Luting metal 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 .

Substantial Equivalence:

Information provided in this 510(k) summary shows that the product is substantially equivalent to 3M ESPE's predicate device, RelyX™ Luting Plus Cement (K022476).

Bench Test Data Comparison with Substantially Equivalent, Currently MarketedDevice
Properties	Method	Lexus 2DesignSpecification	Lexus2Aveand	RelyXLutingPlus(predicateK022476)
Flexural strength (FS)(MPa)	ISO 9917-2	≥ 10 MPa	pass	pass
Radio-opacity (mm ofAl)	ISO 9917-2	≥1.0mm ofAl	pass	pass
Adhesion to dentin(MPa)	3M ESPE internal	≥2 MPa	pass	pass
Adhesion to enamel(MPa)	3M ESPE internal	≥2 MPa	pass	pass
Adhesion to Metal(MPa)	3M ESPE internal	≥2 MPa	pass	pass
Adhesion to Lava™(MPa) zirconia	3M ESPE internal	≥2 MPa	pass	pass
Adhesion to composites	3M ESPE internal	≥2 MPa	pass	pass
Adhesion to amalgam	3M ESPE internal	≥2MPa	pass	pass
Adhesion to Titanium(MPa)	3M ESPE internal	≥2 MPa	pass	pass
Adhesion to Lithiumdisilicate (MPa)	3M ESPE internal	≥2 MPa	pass	pass
Fluoride release (µgF/g) at 90 days	3M ESPE internal	≥500	pass	pass
Film thickness(microns)	ISO 9917-2	≤ 25	pass	pass
Work time (s)	3M ESPE internal	≥ 90s	pass	pass
Set time (s)	3M ESPE internal	<480s	pass	pass

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Environmental, health and safety (EHS) risks for RelyX™ Luting Plus Automix were evaluated using a process compliant with ISO14971:2007, Medical Devices - Application of Risk Management to Medical Devices and with specific procedures and practices outlined by 3M ESPE's Standard Operating Procedures. The conclusion of the risk assessment is that the product RelyX™ Luting Plus Automix is safe for its intended use.

A biocompatibility assessment was developed for this new product using ISO 10993-1:2009(E) Biological evaluation of medical devices.Testing included Genotoxicity, cytotoxicity, sensitization, and systemic toxicity. The conclusion of the assessment is that the product RelyX™ Luting Plus Automix is safe for its intended use.

Combined with biocompatibility testing, based on a comparison of intended use and indications for use, contraindications, physical properties, and composition, 3M ESPE concludes that RelyX™ Luting Plus Automix is substantially equivalent to the named predicate device RelyX™ Luting Plus Cement (K022476). No new concerns about safety or effectiveness have been identified.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

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

3M ESPE Dental Products C/O Mr. Bernardo Medellin Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAY - 5 2011

Re: K111185

Trade/Device Name: RelyX Luting Plus Automix - Resin Modified Glass Ionomer Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: April 26, 2011 Received: April 27, 2011

Dear Mr. Medellin:

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: CDRFI 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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Page 2- Mr. Medellin

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 device-related 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/CDRH/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,

Jamshed Dastoor

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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):

Device Name: RelyX™ Luting Plus Automix - Resin Modified Glass Ionomer Cement

Indications for Use:

This device is intended for use as a dental cement. RelyX™ Luting Plus Automix

(Lexus-2) is indicated for Luting:

Luting porcelain fused to metal crowns and . bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
Luting metal 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

Prescription Use _______ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

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

. '

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Purser
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111185

RelyX™ Luting Plus Automix Resin Modified Glass lonomer Cement 510(k) 3M ESPE Dental Products Confidential Appendix 8

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.