Orthograde root canal filling material
Repair of root perforations during root canal therapy(endodontic therapy), or as a consequence of internal and external resorption.
Repair of root canals as an apical plug during apexification
Root end filling
Pulp capping

Device Description

The major compositions of the RetroMTA-OrthoMTA II are dicalcium silicate, tricalcium silicate and tricalcium aluminate, and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and is used in a putty form which gradually hardens in the oral environment. RetroMTA-OrthoMTA II is ideal for orthograde root canal filling. It is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Setting time	5h 30m	2m 30s
Solubility	3%	1.4%
Radiopacity	Not less than 3mm of aluminum	Not less than 3mm of aluminum
Cytotoxicity	Met preset test criteria (ISO 10993-5)	Met preset test criteria (ISO 10993-5)
Oral Mucous Irritation & Sensitization	Met preset test criteria (ISO 10993-10)	Met preset test criteria (ISO 10993-10)
Acute systemic toxicity	Met preset test criteria (ISO 10993-11)	Met preset test criteria (ISO 10993-11)
Appearance	Met preset test criteria	Met preset test criteria
Weight	Met preset test criteria	Met preset test criteria
Package integrity	Met preset test criteria	Met preset test criteria

Note: The provided document primarily references the predicate device's performance as the de facto acceptance criteria for the subject device. The new device is considered "substantially equivalent" if it meets or improves upon these values and doesn't raise new safety/effectiveness questions.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not include information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The performance data cited are from non-clinical (bench) testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the study described is a non-clinical (bench) study involving physical and chemical property testing, not an evaluation requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is a non-clinical (bench) study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text. The study focuses on comparing the physical and biocompatibility properties of the subject device to a predicate device.

6. Standalone Performance Study

Yes, a standalone study was performed. The "Performance Data (Non-Clinical)" section describes various bench tests conducted on the RetroMTA-OrthoMTA II according to ISO standards and other bench testing. This evaluates the algorithm's (in this context, device's) intrinsic performance against established criteria.

7. Type of Ground Truth Used

The "ground truth" used for this study was established standards and preset test criteria as defined by ISO standards (ISO 6876, ISO 10993-5, ISO 10993-10, ISO 10993-11) and internal "preset test criteria" for other bench tests. For instance, radiopacity had a specific quantitative standard ("Not less than 3mm of aluminum").

8. Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This is a medical device submission based on physical and biological property testing, not an AI/machine learning algorithm that typically requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set mentioned in the context of this device submission.

Summary

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510(k) Summary (K132825)

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

04/08/2014 Date: ________________________________________________________________________________________________________________________________________________________________________

1. Submission Applicant / Submitter:

BioMTA 41, Techno 8-ro, Yuseong-gu, Daejeon, · Republic of Korea 305-500

Tel: +82-42-935-8926~9 . Fax: +82-42-936-8927

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton, CA 92831 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com ·

3. Device:

Proprietary Name:	RetroMTA-OrthoMTA II
Common Name:	Root Filling Material
Classification Name:	Root Canal Filling Resin
Classification:	Class II, 21 CFR 872.3820
Classification Product Code:	KIF

4. Predicate Device:

OrthoMTA(K102575) by BioMTA

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5. Device Description:

6. Intended Use:

The RetroMTA-OrthoMTA II is indicated for use as:

Orthograde root canal filling material -
-Repair of root perforations during root canal therapy(endodontic therapy), or as a consequence of internal and external resorption.
-Repair of root canals as an apical plug during apexification
Root end filling -
Pulp capping -

7. Performance Data(Non-Clinical):

The following properties were tested based on the referenced standards. All the test results met the preset test criteria.

· ISO 6876 Setting time, Solubility and Radiopacity
ISO 10993-5 Cytotoxicity
ISO 10993-10 Oral Mucous Irritation & Sensitization
· ISO 10993-11 Acute systemic toxicity
· Other bench testing Appearance, weight, and package integrity

8. Substantial Equivalence

The RetroMTA-OrthoMTA II is substantially equivalent to the OrthoMTA(Mineral Trioxide Aggregate) (K102575) manufactured by BioMTA. The difference between RetroMTA-OrthoMTA II and the predicate device is that the RetroMTA-OrthoMTA II uses zirconium oxide replacing bismuth oxide which was used in the predicate device. The use of zirconium oxide allows shorter setting time.

The bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that RetroMTA-OrthoMTA II is safe, effective and substantially equivalent to the predicate device.

The table on the following page summarizes technological characteristics of the subject device as compared to the predicate.

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Properties	Subject Device	Predicate Device
510(k) Number	K132825	K102575
Device Name	RetroMTA-OrthoMTA II	OrthoMTA(Mineral Trioxide Aggregate)
PhysicalProperties	-Setting time: 2m 30s-Solubility: 1.4%-Radiopacity: Not less than 3mm ofaluminum	- Setting time: 5h 30m- Solubility: 3 %- Radiopacity: Not less than 3mm ofaluminum- Flow: Not less than 20 mm- Working time: Less than 30min- Film thickness: 27 um- Dimensional change followingsetting : 0.08%

. 9. Conclusion:

Based on the testing results, BioMTA concludes that the RetroMTA-OrthoMTA II is substantially equivalent to predicate device. (

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 10, 2014

BioMTA C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E Chapman Avenue, Suite 110 Fullerton, CA 92833

Re: K132825

Trade/Device Name: RetroMTA-OrthoMTA II Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: February 25, 2014 Received: March 4, 2014

Dear Ms. Chung:

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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Page 2 - Ms. Chung

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary-S. Runner -S

Erin I. Keith, M.S. 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: December 31, 2013 See PRA Statement on last page.

510{k) Number (if known) K132825

Device Name RetroMTA-OrthoMTA II

Indications for Use (Describe)

The RetroMTA-OrthoMTA II is indicated for use as:

Orthograde root canal filling material
Repair of root perforations during root canal therapy(endodontic therapy), or as a consequence of internal resorption.
Repair of root canals as an apical plug during apexification
Root end filling
Pulp capping

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

A SERVED LA SHORT CALL CONFOR FOR FOR FOR FOR FOR FOR FOR THE OFFICE

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/5/Picture/18 description: The image shows the name "Sheena A. Green-S" in bold, black font at the top. Below the name is the date and time "2014.04.10 07:38:46 -04'00'" also in bold, black font. The text appears to be extracted from a document or a form, and the date and time might indicate when the document was created or modified.

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.