The MTA2.3 ROOT & PULP MATERIALS are indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.

Device Description

The MTA2.3 ROOT & PULP MATERIALS are designed and developed for dental clinicians to use in contact with vital pulp tissue and periradicular tissue, including sealing and obturation of root canals. The materials can be used for dental procedures contacting pulpal or periradicular tissue such as: pulp capping, cavity lining, base material in a cavity, pulpotomies, root-end filling, apexification, perforation repair, root resorption, and obturation (pulpectomy) including root canal sealing.

MTA2.3 ROOT & PULP MATERIALS were developed in 2 forms (designs): powder with water-based gel, and pastes. The dentist may choose to mix the powder and water-based gel of MTA2.3 (design 1), or choose to use a paste form of MTA2.3 (design 2). The MTA2.3 ROOT & PULP MATERIALS are placed in the space created by the procedure and set in vivo. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. Such procedures are performed on primary and secondary dentition. MTA2.3 ROOT & PULP MATERIALS may be white or tinted yellow, pink or gray. MTA2.3 ROOT & PULP MATERIALS are color stable over time.

AI/ML Overview

The provided text is a 510(k) summary for the MTA2.3 ROOT & PULP MATERIALS. It describes a medical device, its intended use, technological characteristics, and comparison to a predicate device to demonstrate substantial equivalence for regulatory clearance. It does not describe a study that uses a machine learning algorithm or AI for medical image analysis. Therefore, it is unable to provide the requested information regarding acceptance criteria and a study proving a device meets them for an AI/ML context.

The document discusses the physical and chemical properties of a dental material, its biocompatibility, and conformance to international standards (ISO, ADA). It states: "No animal or human clinical tests were performed in the development of the MTA2.3 ROOT & PULP MATERIALS." This explicitly indicates the absence of the type of clinical performance study (e.g., MRMC or standalone) you are asking about, which are common for AI/ML medical devices.

Therefore, I cannot provide the requested information from this document. It does not contain data on:

A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
Sample sizes for test sets in an AI/ML context, nor data provenance for such.
Number of experts, their qualifications, or adjudication methods for ground truth in an AI/ML context.
MRMC studies or effect sizes of AI assistance.
Standalone algorithm performance.
Type of ground truth (expert consensus, pathology, outcomes data) relevant to AI/ML image analysis.
Sample sizes for training sets in an AI/ML context.
How ground truth for a training set in an AI/ML context was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 11, 2019

NuSmile, LTD. Angie Bever Regulatory Affairs & Quality Assurance Specialist 3315 W 12th Street Houston, Texas 77008

Re: K181917

Trade/Device Name: MTA2.3 Root & Pulp Materials Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: October 24, 2018 Received: October 25, 2018

Dear Angie Beyer:

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.

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

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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 medical devices and radiation-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. Digitally signed by Marv Mary S. ה Mrary -5.
Runner -533 - Date: 2019.01.11 10:59:11
Runner -533 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - For Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICESForm Approved: OMB No. 0910-0120Food and Drug AdministrationExpiration Date: 06/30/2020Indications for UseSee PRA Statement below.510(k) Number (if known)K181917Device NameMTA2.3 ROOT & PULP MATERIALSIndications for Use (Describe)The MTA2.3 ROOT & PULP MATERIALS are indicated for dental procedures that contact pulp and periradiculartissues, as well as obturation and sealing of root canals.Type of Use (Select one or both, as applicable)Over-The-Counter Use (21 CFR 801 Subpart C)X Prescription Use (Part 21 CFR 801 Subpart D)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 1PSC Publishing Services (301) 443-674

MTA2.3 ROOT & PULP MATERIALS

26 NuSmile, Ltd.

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K181917

510(k) Summary

per 21CFR807.92 & 807.93

I. SUBMITTER

DATE PREPARED: June 30, 2018

PREPARER: Angie Beyer Regulatory & QA Specialist NuSmile, Ltd. 3315 W, 12th Street Houston, TX 77008 USA www.nusmile.com Phone: (713) 861-0033 xtn. 559 Fax: (713) 861-1722 E-mail: regulatory@nusmile.com Web: http://www.nusmile.com/

II. DEVICE

TRADE OR PROPRIETARY NAME: CLASSIFICATION NAME: PREDICATE DEVICE:

MTA2.3 ROOT & PULP MATERIALS Root Canal Filling Resin, 872.3820 K161239, MTA2.2 material

III. PREDICATE DEVICES

MTA2.3 ROOT & PULP MATERIALS are substantially equivalent to the following predicate devices with respect to intended use, indications for use, materials, technological characteristics, and device design.

510(k) #	Device	Manufacturer
K161239	MTA2.2	Avalon Biomed Inc.*,
		*assets of Avalon Biomed were acquired by NuSmile, Ltd.(2016), including 510(k)s

The predicate has not been subject to a recall.

MTA2.3 ROOT & PULP MATERIALS have been modified from MTA2.2 MATERIAL to allow for more radiopacity and varied clinical handling characteristics.

IV. DEVICE DESCRIPTION:

Premarket Notification

MTA2.3 ROOT & PULP MATERIALS

28 NuSmile, Ltd.

MTA 2.3 ROOT & PULP MATERIALS

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The mechanism of action is for the subject and predicate devices is setting of the inorganic, ceramic cement in the presence of the water-based body fluids present in teeth.

MTA2.3 ROOT & PULP MATERIALS were developed in 2 forms (designs): powder with water-based gel, and pastes. The dentist may choose to mix the powder and water-based gel of MTA2.3 (design 1), or choose to use a paste form of MTA2.3 (design 2). The MTA2.3 ROOT & PULP MATERIALS are placed in the space created by the procedure and set in vivo. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. Such procedures are performed on primary and secondary dentition. MTA2.3 ROOT & PULP MATERIALS may be white or tinted vellow, pink or grav. MTA2.3 ROOT & PULP MATERIALS are color stable over time.

V. INDICATIONS FOR USE:

The MTA2.3 ROOT & PULP MATERIALS are intended for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.

These indications are identical to the predicate K161239, MTA2.2 MATERIAL.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

TECHNOLOGICAL CHARACTERISTICS: The MTA2.3 ROOT & PULP MATERIALS are primarily hydraulic ceramic powders, as is the MTA2.2 MATERIAL (K161239). The ceramic powders set in vivo in contact with body fluids. The technology is unchanged.

The hydrophilic ceramic powders are known to set with water into a hard substance, containing a high pH, calcium hydroxide reaction product, dispersed among the hydrated particles of tri/dicalcium silicates. Both the predicate and the subject materials are radiopaque and contain the same ceramic oxide for radiopacity.

COMPARISONS TO PREDICATE: We believe the MTA2.3 ROOT & PULP MATERIALS are substantially equivalent to the MTA2.2 material (K161239) when used for contact with pulp tissue and periapical tissue, as well as obturation and sealing of root canals.

The modifications to the predicate MTA2.2 material (K161239) are an increase in the radiopaque component, and modified liquids for the convenience delivery into the tooth by the clinician. These modifications do not change the intended use, indications for use, or technological characteristics. The modifications do not raise any new questions of safety or effectiveness.

Similarities: The predicate MTA2.2 material and the modified MTA2.3 ROOT & PULP MATERIALS are based on the inorganic ceramic powders composed of primarily tricalcium silicate, dicalcium silicate, and tantalite for radiopacity. The predicate and the MTA2.3 ROOT & PULP MATERIALS rely on water-based fluids in the body to hydrate the hydraulic ceramic phases, and cause setting into a hard substance containing hydrated silicates and hydroxides. MTA2.3 ROOT & PULP MATERIALS may contain the same inorganic ceramic pigments, at minor levels, as were cleared for MTA2.2 materials.

Premarket Notification

MTA2.3 ROOT & PULP MATERIALS

29 NuSmile, Ltd.

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Both the MTA2.3 ROOT & PULP MATERIALS and the predicate MTA2.2 material are similar because they are:

o ceramic cements,
used in root canals or on vital pulp tissue O
used for sealing and obturation of root canals O
suitable for use in primary dentition for pulpal treatment O
are based on ceramic powders that set with water O
are radiopaque O
do not discolor o
set in vivo with contact with water-based body fluids. o

The new and predicate materials have similar compositions and properties. Both MTA2.3 ROOT & PULP MATERIALS and the predicate MTA2.2 material create a high pH environment, which induces the precipitation of hydroxyapatite-like crystals in synthetic body fluid when the tri/dicalcium silicate powder component is hydrated.

Differences: MTA2.3 ROOT & PULP MATERIALS are more radiopaque than MTA2.2 material.

MTA2.3 ROOT & PULP MATERIALS may be packaged with a modified water-based liquid for mixing, or premixed with an organic liquid.

The similarities and differences are summarized in Table VI-1. Two design modifications are being submitted. The two designs are described in Table VI-2.

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	Predicate DeviceMTA2.2 Material	Subject DeviceMTA2.3 ROOT & PULP MATERIALS
510(k) Number	K161239	K18XXXX
Manufacturer	Avalon Biomed Inc.	NuSmile, Ltd.1
Device Name	MTA2.2	MTA2.3
Description	Root canal filling resin	Root canal filling resin
Medical Specialty	Dental	Dental
Product Code	KIF	KIF
Reg Number	872.3820	872.3820
Class	2	2
Indications forUse	The MTA2.2 MATERIAL is indicatedfor dental procedures that contactpulp and periradicular tissues, aswell as obturation and sealing ofroot canals.	The MTA2.3 ROOT & PULP MATERIALSare indicated for dental procedures thatcontact pulp and periradicular tissues,as well as obturation and sealing of rootcanals.
Sterility	Non-Sterile	Non-Sterile
Utility	Single-use Only- for each dosedispensed from a multi-usecontainer	Single-use Only- for each dosedispensed from a multi-use container
Materials	Powder: Tri/dicalcium silicate withtantalum oxide.Liquid: Water-based gel withpolymers.	Powder: Tri/dicalcium silicate withmore tantalum oxide. One design hasadditional ceramic powders.Liquid: Water-based gel with thickeners& proprietary additivesOR an organic liquid as described foreach design.

Table VI-1: Comparison of Subiect MTA2.3 to Predicate (MTA2.2 Materials, K161239)

Table VI-2: Description of Predicate (MTA2.2 K161239) and Subject MTA2.3 Designs

Predicate design	Powder based on water-setting cements
	Radiopaque with tantalite
	Water-based gel containing polymers
	Powder and gel to be mixed prior to use by clinician
Designmodification-1	Powder contains same components as predicate with more tantalite
	Water-based gel with more thickening agents & other additives thanpredicate
	Powder and gel to be mixed prior to use by clinician
Designmodification-2	Powder contains same components as predicate with more tantalite.
	Powder contains additional ceramic additives for handling.
	Powder supplied as a paste, or a powder to the clinician.

1 NuSmile, Ltd. purchased the assets of Avalon Biomed Inc. in 2016, including the prior 510(k) licenses.

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VII. PERFORMANCE DATA

NON-CLINICAL PERFORMANCE: Bench testing of the physical properties of the MTA2.3 ROOT AND PULP MATERIALS was performed to verify conformance to ISO 6876, ADA 57, and ISO 9917-1, as they apply. We believe that the performance data provided herein demonstrate that MTA2.3 ROOT AND PULP MATERIALS are substantially equivalent to the predicate MTA2.2 material (K161239) in design, principle of performance, technology, and composition. We believe the MTA2.3 ROOT & PULP MATERIALS perform as well as or better than the predicate device.

As part of design validation, MTA2.3 ROOT & PULP MATERIALS met the ISO 6876 standard for radiopacity, solubility, dimensional stability, film thickness, and flow. The ISO 6876 tests were also performed to measure the working time and setting time of MTA2.3 ROOT & PULP MATERIALS. Tests for arsenic and lead were performed to ensure conformance to ISO 9917-1 requirements. We believe that the performance data provided herein demonstrate that MTA2.3 ROOT AND PULP MATERIALS are substantially equivalent to the predicate MTA2.2 material (K161239) in design, principle of performance, technology, and composition. We believe the MTA2.3 ROOT & PULP MATERIALS perform as well as or better than the predicate device.

BIOCOMPATIBILITY: The MTA2.3 ROOT & PULP MATERIALS were evaluated for biocompatibility as part of design validation. The materials were not cytotoxic. See Appendix C and Section 16.

CLINICAL PERFORMANCE: No animal or human clinical tests were performed in the development of the MTA2.3 ROOT & PULP MATERIALS.

MTA2.3 ROOT & PULP MATERIALS have a similar composition to the predicate device. All of the components found in the MTA2.3 ROOT & PULP MATERIALS have been used in legally marketed devices.

VIII. CONCLUSIONS

No substantial differences in terms of technology are known between the MTA2.3 ROOT & PULP MATERIALS and the predicate device. The main difference in the modified material is additional radiopaque component. Secondary differences include a modified gel for one design, and use of an organic liquid in the second design. The compositional changes do not raise any new issues of risk, safety and effectiveness. Therefore, we believe that the information provided herein demonstrates that the MTA2.3 ROOT & PULP MATERIALS are substantially equivalent to the predicate device in technology, design, principles of performance, and intended use.

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.