3MTM RelyX™ Pediatric Resin Modified Glass Ionomer Cement is a radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. RelyX Pediatric Cement is intended for the cementation of preformed pediatric crowns made of stainless steel, zirconia, and resin composite material.

RelyX Pediatric Cement consists of a base paste and a catalyst paste packaged in the Automix delivery system for direct delivery in consistent mix ratios. The mixing tip attachment offers convenience over traditional hand mixed cement systems and delivers consistent mix ratios. The cement is available in a white shade. The Automix syringe contains 8.5 g of cement material. The product provides both selfcuring and light curing mechanisms which makes it uniquely versatile for the cementation of different restorative materials.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study details for the 3M™ RelyX™ Pediatric Resin Modified Glass Ionomer Cement, based on the provided text:

Important Note: The provided document is a 510(k) summary for a dental cement. It does not describe an AI medical device, but rather a traditional medical device that undergoes physical and chemical performance testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested fields related to AI, such as sample sizes for test/training sets, data provenance, ground truth experts, adjudication methods, and MRMC studies, are not applicable and thus not present in this type of document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the demonstration of "equivalent or superior bonding" and other physical properties compared to predicate devices. The document does not explicitly list numerical acceptance criteria in a table format for each property, but rather states that the "results submitted in the 510(k) demonstrated equivalent or superior bonding."

Here's a table based on the reported performance relative to predicate devices:

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Adhesion to Dentin	Equivalent to or superior to predicate devices (K111185, K001730)	Demonstrated equivalent or superior bonding
Adhesion to Enamel	Equivalent to or superior to predicate devices (K111185, K001730)	Demonstrated equivalent or superior bonding
Adhesion to 3M Pediatric Esthetic Crown	Adequate performance for indicated use (specific to the new indication)	Demonstrated equivalent or superior bonding
Compressive Strength	Performance comparable to predicate devices	Data included in submission to evaluate performance for new indication
Flexural Strength	Performance comparable to predicate devices	Data included in submission to evaluate performance for new indication
Fluoride Release	Performance comparable to predicate devices	Data included in submission to evaluate performance for new indication
Linear Expansion	Performance comparable to predicate devices	Data included in submission to evaluate performance for new indication
Radiopacity	Performance comparable to predicate devices	Data included in submission to evaluate performance for new indication
Color Stability	Performance suitable for esthetic properties (specific to the new indication)	Data included in submission to evaluate performance for new indication
Biocompatibility	Meets biocompatibility requirements (ISO 10993-1:2018)	Confirmed to meet requirements; no additional testing needed due to identical formulation as predicate device
Shelf Life	24 months at room temperature	Established as 24 months based on predicate device testing

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The document mentions "data from in vitro testing," which typically involves multiple samples for each test (e.g., several samples per group for adhesion tests, compressive strength, etc.), but the exact number is not provided.
- Data Provenance: The studies were in vitro testing. The country of origin of the data is not specified, but the submitter is 3M ESPE Dental Products, located in St. Paul, MN, USA. The testing was conducted to support a 510(k) submission to the U.S. FDA. The studies are by nature prospective in the sense that the manufacturer performed them to gain clearance for the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is not an AI/diagnostic device. The "ground truth" for material properties is established through standardized physical and chemical testing methods (e.g., ISO standards), not expert consensus.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of in vitro material performance testing. Standardized test methods and measurements are used, not human adjudication.
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 an AI medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and chemical properties (adhesion, strength, fluoride release, etc.), the "ground truth" is determined by the results obtained from standardized in vitro test methods (e.g., per FDA Guidance "Dental Cements - Premarket Notification" and ISO 9917-2:2017). For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993-1:2018.
The sample size for the training set:
- Not applicable. This is not an AI medical device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. This is not an AI medical device, so there is no "training set" or corresponding ground truth establishment process in that context.

Summary

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May 29, 2019

3M ESPE Dental Products % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K191122

Trade/Device Name: 3M RelyX Pediatric Resin Modified Glass Ionomer Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental cement Regulatory Class: Class II Product Code: EMA Dated: April 26, 2019 Received: April 29, 2019

Dear Mark Job:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Malvina B Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120
Indications for Use	Expiration Date: 06/30/2020See PRA Statement below.
510(k) Number (if known)	K191122
Device Name	3M™ RelyX™ Pediatric Resin Modified Glass Ionomer Cement
Indications for Use (Describe)	Permanent cementation of pediatric crowns:• Stainless Steel crowns• Zirconia crowns• 3M™ Pediatric Esthetic Crowns
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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)	Page 1 of 1
	PSC Publishing Service (201)-443-6740

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510(k) Summary 3.

ЗМ ЕЅРЕ Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000

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510(k) Summary

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

510(k) Submitter	3M ESPE Dental Products2510 Conway Ave.St. Paul, MN 55144 USA
Contact person	Lin Ma, Ph. D.Regulatory Affairs SpecialistOffice: (651) 733-4734Fax: (651) 736-1599lma@mmm.com
Date Summary was Prepared	28 March 2019
Trade Name	3M™ RelyX™ Pediatric ResinModified Glass Ionomer Cement
Common Name(s)	Dental Cement, Resin ModifiedGlass Ionomer
Recommended Classification	21 CFR 872.3275Dental CementProduct Code: EMA
Predicate Devices
Primary Predicate	3M™ ESPE™ RelyX™ Luting Plus Automix ResinModified Glass Ionomer Cement (K111185)
Secondary Predicate	GC FujiCEM™ 2 Radiopaque Reinforced GlassIonomer Luting Cement (K001730)

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Description of Device:

Indications for Use:

Permanent cementation of pediatric crowns:

. Stainless Steel Crowns
. Zirconia Crowns
3MTM Pediatric Esthetic Crowns .

Technological Characteristics:

Luting cements, including resin modified glass ionomer cements, are widely used to cement crowns for children and adults. Luting cements fill the gap between the crown and prepared tooth; the cured cements provide the mechanical interlock between the crown and the tooth structure. The cured resin modified glass ionomer cements not only provide strong mechanical property but also interfacial adhesion to different materials. These properties ensure the longevity of dental restoration for patients. The unique chemistry of resin modified glass ionomer cements provides strong interfacial adhesion to different materials.

RelyX Pediatric Cement is identical to the predicate device, 3M RelyX Luting Plus Automix, in terms of formulation and delivery. RelyX Pediatric Cement is marketed specifically for use with pediatric crowns of stainless steel or zirconia. with an additional indication to cement the 3M Pediatric Esthetic Crown, which is a resin composite crown.

Bonding between the cement and tooth structure or the restorative material occurs by two mechanisms: mechanical bonding through a self-curing mechanism and chemical bonding through a light-curing mechanism. The cement product performs with both self-curing and light-curing mechanisms.

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Self-curing: Two mechanical setting reactions occur through the self-curing mechanism.

. An acid-base reaction between the FAS (fluoroaluminosilicate) glass and methacrylated polycarboxylic acid; and
A free radical polymerization of the methacrylated copolymer and ethylenically ● unsaturated monomers/agents.

Light-curing: Through the light curing mechanism, a chemical bond forms in the presence of the photoinitiation system, camphorquinone (CPQ) and 4-(dimethylamino)-phenethyl alcohol (DMAPE); and can enhance the interaction between the cement and restorative material, specifically in the case of resin composite crowns.

The cementation of stainless steel and zirconia crowns is adequately achieved by the self-curing mechanism. In comparison, the cementation of 3M Pediatric Esthetic Crown requires an additional step of light-curing during the self-curing process to enhance the bonding between the cement and the resin composite material. When irradiated by light, the methacrylate functionalities of the resins in conjunction with the photoinitiator system polymerize to form a stronger and quicker bond to the resin composite crown. Therefore, the light cure step enhances an adhesive interaction between RelyX Pediatric Cement and 3M Pediatric Esthetic Crown.

Substantial Equivalence:

Information provided in this 510(k) submission shows that the product is substantially equivalent to the predicate devices, 3M ESPE RelyX™ Luting Plus Automix (K11185) and GC FujiCEM™ 2 Luting Cement (K001730).

	Applicant Device	Primary Predicate	Secondary Predicate
Trade Name	RelyX™ Pediatric	RelyX™ Luting Plus	FujiCEM™ 2
		Automix (K111185)	(K001730)
ProductCategory	Resin Modified GlassIonomer LutingCement	Resin Modified GlassIonomer Luting Cement	Resin Modified GlassIonomer Luting Cement
Intended Use	Dental Luting Cement	Dental Luting Cement	Dental Luting Cement
Indications forUse	Permanent cementationof pediatric crowns:• Stainless Steelcrowns• Zirconia crowns• 3M™ PediatricEsthetic Crowns	RelyX Luting PlusAutomix is indicated forLuting:• Luting porcelainfused to metal crownsand bridges to toothstructure, amalgam,composite or glassionomer core buildups;	1. Cementation ofmetal-based inlays,onlays, crowns andbridges2. Cementation of resininlays, onlays,crowns and bridges3. Cementation of allceramic inlays4. Cementation of highstrength (e. g.
	Applicant Device	Primary Predicate	Secondary Predicate
Trade Name	RelyX™ Pediatric	RelyX™ Luting Plus	FujiCEM™ 2
		Automix (K111185)	(K001730)
		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	zirconia based, lithium disilicate, etc.) all ceramic inlays, onlyas, crowns and bridges Cementation of metal, ceramic and fiber posts
Contra-indication	None	None	1. Pulp capping.2. In rare cases, the product may cause sensitivity in some people. If any such reactions are experienced, discontinue the use of the product and refer to a physician.
Technological	Glass Ionomer Tooth	Glass Ionomer Tooth	The device is set by
Characteristics	bonding properties	bonding properties based	acid-base reaction and
and Mode of	based on		polymerization after
		on
Action - Self	1. An acid-base	1. An acid-base reaction	mixing 2 pastes.
Curing	reaction betweenfluoroalumino-silicate glass andmethacrylatedpolycarboxylic acid;2. A free radicalpolymerization ofthe methacrylatedcopolymer andethylenicallyunsaturatedmonomers/agents;3. The 2 pastes aredelivered in aconsistent mannerthrough an Automixdelivery system.	betweenfluoroalumino-silicateglass andmethacrylatedpolycarboxylic acid;2. A free radicalpolymerization of themethacrylatedcopolymer andethylenicallyunsaturatedmonomers/agents;3. The 2 pastes aredelivered in aconsistent mannerthrough an Automixdelivery system	1. Acid-base reactionoccursfluoroalumino-silicate glass in PasteA and polyacrylicacid in Paste B.2. Polymerization ofmethacrylatemonomers is throughchemical cure.
	Applicant Device	Primary Predicate	Secondary Predicate
Trade Name	RelyX™ Pediatric	RelyX™ Luting PlusAutomix (K111185)	FujiCEM™ 2(K001730)
TechnologicalCharacteristicsand Mode ofAction – LightCuring	Photoinitiator systemwith camphorquinone(CPQ) and 4-(dimethylamino)-phenethyl alcohol(DMAPE):• Tack-curing forexcess removal,• Light-curing forenhancing the bondstrength to 3MPediatric Estheticcomposite crowns	Photoinitiator systemwith camphorquinone(CPQ) and 4-(dimethylamino)-phenethyl alcohol(DMAPE):• Tack-curing for excessremoval	No light curing.

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Image /page/6/Picture/0 description: The image shows the 3M logo. The logo consists of the number "3" and the letter "M" in a bold, sans-serif font. The color of the text is red, and the background is white. The logo is simple and recognizable.

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Image /page/7/Picture/0 description: The image shows the 3M logo. The logo is in red and consists of the number "3" followed by the letter "M". The logo is simple and recognizable, and it is often used on 3M products and marketing materials. The logo is bold and eye-catching.

The technological characteristics and mode of action of RelyX Pediatric Cement is identical to the primary predicate device RelyX Luting Plus Automix in terms of fundamental reactions in self-curing and light-curing modes, in spite of its added enhancement to bond to the resin crown in light-curing mode. RelyX Pediatric Cement is also substantially equivalent to the secondary predicate device GC FujiCEM with respect to the characteristics of resin modified glass ionomer cement and fundamental reactions of acid-base reaction and polymerization.

The safety and efficacy of RelyX Pediatric Cement with stainless steel and zirconia crowns remains unchanged from the primary predicate, 3M RelyX Luting Plus Automix. The indication for use of RelyX Pediatric Cement with stainless steel and zirconia crowns is a subset of the indications for use of the primary predicate device. As RelyX Pediatric Cement is identical to the primary predicate device in formulation and delivery system, no new questions of safety and effectiveness are raised with these indications.

The product was also assessed to ISO 10993-1:2018 and it was confirmed that no additional biocompatibility testing was required to support the submission because the formulation of RelyX Pediatric Cement is identical to the predicate device since the clearance its original 510(k) and continues to meet biocompatibility requirements.

Testing was undertaken to substantiate the use of the RelyX Pediatric Cement with the 3M Pediatric Esthetic Crown, the new indication being added when compared to the predicate devices. This 510(k) submission includes data from in vitro testing per FDA Guidance "Guidance for Industry and FDA Staff Dental Cements - Premarket Notification" issued on August 18, 1998 and ISO 9917-2:2017 Dentistry - Waterbased Cements - Part 2: Resin-modified Cements. To evaluate the performance of RelyX Pediatric Cement with 3M Pediatric Esthetic composite crowns, comparative testing results for the following physical properties were included in this submission:

. Adhesion to dentin and enamel

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Adhesion to 3M Pediatric Esthetic Crown ●
Compressive strength ●
Flexural strength ●
Fluoride release
Linear expansion
Radiopacity
Color Stability for esthetic properties ●

The results submitted in the 510(k) demonstrated equivalent or superior bonding of the 3M RelyX Pediatric Cement to the 3M Pediatric Esthetic Crown, dentin and enamel as compared to the primary and secondary predicates.

The stability studies conducted with the primary predicate device, RelyX™ Luting Plus Automix are applicable to RelyX Pediatric Cement because they are identical in formulations, packaging, and intended use. The established shelf life for RelyX Pediatric Cement is 24 months at room temperature within a sealed foil pouch.

Conclusion:

3MTM RelyX™ Pediatric Resin Modified Glass Ionomer Cement is substantially equivalent to the primary predicate device 3M RelyX™ Luting Plus Automix in terms of intended use, formulation, biocompatibility, physical properties, technological characteristics, and indications for use to cement stainless steel and zirconia crowns. 3MTM RelyX™ Pediatric Cement with additional light curing step is substantially equivalent to the secondary predicate device GC FuiiCEM™ 2 in terms of intended use and the indication for use to cement 3M Pediatric Esthetic Crown, a resin composite crown. Testing has been conducted that demonstrates the 3MTM RelyX™ Pediatric Resin Modified Glass Ionomer Cement performs as intended with the 3M Pediatric Esthetic composite crowns and the new indication for use with the 3M Pediatric Esthetic composite crowns does not raise new questions of safety or effectiveness.

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.