The MTA2.2 MATERIAL is designed and developed for dental clinicians to use in contact with vital pulp tissue and periradicular tissue, including sealing and obturation of root canals. This material 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) in primary or secondary teeth.

The dentist will mix the powder and water-based gel of MTA2.2 and place the mixed MTA2.2 MATERIAL into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. These procedures are performed on primary and secondary dentition and are color stable over time. MTA2.2 MATERIAL is tinted yellow, pink and gray.

AI/ML Overview

This document describes the premarket notification (510(k) submission) for the MTA2.2 MATERIAL, a root canal filling resin. However, it does not present a study with acceptance criteria and reported device performance in the way typically expected for a medical imaging or diagnostic device involving statistical metrics like sensitivity, specificity, or reader studies.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MTA2.1 MATERIAL, K140955) based on material properties, design, indications for use, and conformance to established dental standards.

Therefore, many of the requested sections about acceptance criteria, study design, sample sizes for test/training sets, expert ground truth, adjudication, and MRMC studies are not applicable or cannot be extracted from this document, as they pertain to clinical performance evaluations not present here.

Here's a breakdown of what can be extracted based on the provided text:

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

The "acceptance criteria" here are conformance to recognized consensus standards for dental materials. The "reported device performance" refers to the MTA2.2 MATERIAL meeting these standards.

Acceptance Criteria (Standard Conformance)	Reported Device Performance (MTA2.2 Material)
ISO 6876: Endodontic sealing materials
Flow	Conforms to standard
Film thickness	Conforms to standard
Solubility	Conforms to standard
Setting time	Conforms to standard
Working time	Conforms to standard
Radiopacity	Conforms to standard
ADA 57: Endodontic Sealing Material	(Same as above, as 57 relates to ISO 6876)
Radiopacity	Conforms to standard
Solubility	Conforms to standard
Dimensional stability	Conforms to standard
Film thickness	Conforms to standard
Flow	Conforms to standard
Working time	Conforms to standard
Setting time	Conforms to standard
ISO 9917
Compressive strength	Conforms to standard
Leaching of arsenic and lead	Conforms to standard
Biocompatibility
Cytotoxicity	Evaluated, no adverse findings reported
Washout tests	Confirmed stability
Discoloration tests	Confirmed color stability

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for a "test set" in the context of diagnostic performance. The document describes bench testing of material properties. The specific sample sizes for each bench test (e.g., number of specimens for compressive strength) are not provided.
Data Provenance: Not specified, but likely from laboratory bench testing conducted by the manufacturer, Avalon Biomed Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in this context refers to established material properties measured according to standardized laboratory protocols, not expert consensus on clinical findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication process is described for batch testing of material properties.

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

No. This is a material safety and effectiveness submission, not an AI or diagnostic imaging device. No MRMC study was conducted or is relevant.

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

No. This is not an algorithmic device.

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

The "ground truth" for the performance data in this document is derived from measurements of physical and chemical properties according to established and recognized consensus standards (ISO 6876, ADA 57, ISO 9917).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design, creating a sense of interconnectedness and service.

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

September 1, 2016

Avalon Biomed Inc. Carolyn Primus President 1912 44th Ave E Bradenton, Florida 34203

Re: K161239

Trade/Device Name: Mta2.2 Material Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: May 31, 2016 Received: June 7, 2016

Dear Carolyn Primus:

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.

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.

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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,

Michael J. Ryan -S

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 SERVICES
Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K16

Device Name MTA 2.2

Indications for Use (Describe)

The MTA2.2 MATERIAL is indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.

Type of Use (Select one or both, as applicable)

Z 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 the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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."

FORM FDA 3881 (8/14)

Page 1 of 1

не

Premarket Notification (Special)

MTA2.2 MATERIAL

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510(k) Summary

per 21CFR807.92

I. SUBMITTER

DATE PREPARED: April 24, 2016 Carolyn Primus, President Avalon Biomed Inc. 7282 55th Ave E # 227 Bradenton, FL 34203 USA www.avalonbiomed.com Phone: (941) 896-9948 Fax: (941) 896-9950 E-mail: cprimus@avalonbiomed.com Web: http://www.avalonbiomed.com/

II. DEVICE

TRADE OR PROPRIETARY NAME: MTA2.2 MATERIAL CLASSIFICATION NAME: PREDICATE DEVICE: K140955, MTA2.1 ROOT AND PULP MATERIALS

III. PREDICATE DEVICES

MTA 2.2 MATERIAL IS substantially equivalent to the following predicate devices with respect to intended use, indications for use, materials, technological characteristics, and device design. MTA2.2 MATERIAL has been slightly modified from MTA2.1 MATERIAL to allow for more radiopacity and slightly different handling characteristics. The predicate has not been subject to a recall.

510(k) # Manufacturer K140955 MTA2.1 Avalon Biomed Inc

IV. DEVICE DESCRIPTION:

V. INDICATIONS FOR USE:

The MTA2.2 MATERIAL is intended for use for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals This is identical to the predicate K140955, MTA 2.1 MATERIAL.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

TECHNOLOGICAL CHARACTERISTICS: The MTA2.2 MATERIAL is primarily hydraulic tri/dicalcium silicate powder as is the MTA2.1 MATERIAL (K140955). The tri/dicalcium silicate powders are known to set with water into a hard substance, containing calcium hydroxide dispersed among the hydrated particles of tri/dicalcium silicates. Both materials are radiopaque.

COMPARISONS TO PREDICATE: We believe the MTA2.2 MATERIAL is substantially equivalent to the MTA2.1 ROOT AND PULP MATERIAL (K140955) when used for contact with pulp tissue and periapical tissue, and as a root canal sealer.

The modification to the predicate MTA2.1 ROOT AND PULP MATERIAL (K140955) is an increase in the radiopaque component. This modification does not affect indications for use or technology. It does not raise any new questions of safety or effectiveness. The waterbased gel has a slightly modified composition.

Similarities: The predicate MTA2.1 ROOT AND PULP MATERIALS and the modified MTA2.2 MATERIAL are based on the same inorganic powder composed of primarily tricalcium silicate, dicalcium silicate, and a radiopaque inorganic oxide. The predicate and the MTA2.2 ROOT AND PULP MATERIAL rely on water to hydrate the calcium silicate phases, and cause setting into a hard substance containing hydrated silicates and some calcium hydroxide.

Both the MTA2.2 MATERIAL and the predicate MTA2.1 ROOT AND PULP MATERIALS are used in root canals or on vital pulp tissue. Both the MTA2.2 MATERIAL and the predicate MTA2.1 ROOT AND PULP MATERIALS are used for sealing and obturation of root canals. Both the MTA2.2 MATERIAL and the predicate MTA2.1 ROOT AND PULP MATERIALS are suitable for use in primary dentition without causing long-term discoloration. The MTA2.2 MATERIAL and the predicate MTA2 ROOT AND PULP MATERIALS are similar because both kits contain the same gel.

The new and predicate materials have similar compositions, film thickness, flow and compressive strengths, when mixed at similar powder to liquid/gel ratios. Both MTA2.2 MATERIAL and the predicate MTA2.1 ROOT AND PULP MATERIALS induce the precipitation of hydroxyapatite crystals in synthetic body fluid because of the tricalcium silicate powder component.

Differences: MTA2.2 MATERIAL is more radiopaque than MTA2.1 ROOT AND PULP MATERIALS. MTA2.2 material may be slightly different in color than the MTA2.1 ROOT AND PULP MATERIALS, although the inorganic pigments are the same.

We believe that the performance data provided herein demonstrate that MTA2.2 ROOT AND PULP MATERIALS are substantially equivalent to the predicate MTA2.1 (K140955) in design, principle of performance, technology, and composition. We believe the MTA2.2 MATERIAL performs as well as or better than the predicate device.

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Table VI-1: Comparison of Subject MTA2.2 to Predicate (MTA2.1 K140955)
	Subject DeviceMTA2.2	Predicate DeviceMTA2.1
510(k) Number	K16	K140955
Manufacturer	Avalon Biomed Inc.	Avalon Biomed Inc.
Device Name	MTA2.2	MTA2.1
Description	Root canal filling resin	Root canal filling resin
MedicalSpecialty	Dental	Dental
Product Code	KIF	KIF
Reg Number	872.3820	872.3820
Class	2	2
Materials	Powder: Tri/dicalcium silicatewith radiopaque additive.Liquid: Water-based gel	Powder: Tri/dicalcium silicatewith radiopaque additive.Liquid: Water-based gel
Design	Powder and gel to be mixed priorto use by clinician.More radiopaqueWater-based-gel	Powder and gel to be mixed priorto use by clinician.RadiopaqueWater-based gel
Indications forUse	The MTA2.2 MATERIAL isindicated for dental proceduresthat contact pulp andperiradicular tissues, as well asobturation and sealing of rootcanals	The MTA2.1 MATERIAL isindicated for dental proceduresthat contact pulp andperiradicular tissues, as well asobturation and sealing of rootcanals
Sterility	Non-Sterile	Non-Sterile
Utility	Single-use Only	Single-use Only

Table VI-1: Comparison of Subiect MTA2.2 to Predicate (MTA2.1 K140955)

VII. PERFORMANCE DATA

NON-CLINICAL PERFORMANCE: Bench testing was performed as part of design validation to demonstrate continued conformance with the requirements were achieved to conform to the FDA recognized standards ADA 57 and appropriate requirements of ISO 9917. As part of design validation, MTA2.2 MATERIAL met the ADA 57 standard for radiopacity, solubility, dimensional stability, film thickness, and flow. The ADA 57 tests were also performed to measure the working time and setting time of MTA2.2 compared to the predicates. Tests for compressive strength and leaching of arsenic and lead were performed to shown conformance to ISO 9917. Washout tests confirm the stability of the material. Discoloration tests confirm the color stability of the material.

MTA2.2 conforms to the recognized consensus standards:

ISO 6876: Endodontic sealing materials ●
ADA 57: Endodontic Sealing Material

MTA2.2 was test for conformance to these standards for flow, film thickness, solubility, setting time, working time, and radiopacity.

The MTA2.2 MATERIAL was evaluated for biocompatibility with its gel in cytotoxicity test as part of design validation.

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CLINICAL PERFORMANCE: No animal clinical tests were performed in the development of the MTA2.2 MATERIAL.

All of the components found in the MTA2.2 have been used in legally marketed devices and were found safe for dental use. MTA2.2 material has a similar composition to the predicate device.

VIII. CONCLUSIONS

No substantial differences in terms of composition and mechanical properties are known between the MTA2.2 and the predicate device. The difference in the modified material is the addition of additional radiopaque component and a modification of the gel. The change does not raise any new issues of safety and effectiveness. The technological characteristics, safety, effectiveness and materials are identical to MTA 2.1 (K140955). Therefore, we believe that the information provided herein demonstrates that the MTA2.2 is substantially equivalent to the predicate devices in 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.