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

Device Description

Ortho MTA (Mineral Trioxide Aggregate) is ideal for orthograde root canal filling. Ortho MTA (Mineral Trioxide Aggregate) is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.

AI/ML Overview

The provided text describes a medical device called Ortho MTA (Mineral Trioxide Aggregate), a root canal filling material, and its substantial equivalence to a predicate device, White MTA Material (K011009). The document focuses on demonstrating that Ortho MTA has similar properties and performance to the predicate device, thus not raising new questions about safety and effectiveness.

However, the provided text does not include specific quantitative acceptance criteria or a detailed study methodology that would typically be used to prove a device meets such criteria in the way a diagnostic AI device would. Instead, it relies on demonstrating "similar physical and biocompatible properties" and "comparable performance specifications" to a predicate device.

Therefore, many of the requested items related to acceptance criteria, sample size, expert ground truth, adjudication, and AI-specific studies cannot be extracted from this document, as they are not present.

Here's a summary based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of specific performance metrics with acceptance criteria, as one might see for a diagnostic AI, is not present here. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Similar physical properties to predicate device	Ortho MTA has similar physical properties to White MTA Material. (Explicit statement: "Ortho MTA... has similar physical... properties, and demonstrates comparable performance specifications to White MTA Material")
Similar biocompatible properties to predicate device	Ortho MTA has similar biocompatible properties to White MTA Material. (Explicit statement: "Ortho MTA... has similar physical and biocompatible properties, and demonstrates comparable performance specifications to White MTA Material")
Comparable performance specifications to predicate device	Ortho MTA demonstrates comparable performance specifications to White MTA Material. (Explicit statement: "Ortho MTA... has similar physical and biocompatible properties, and demonstrates comparable performance specifications to White MTA Material")
Comparable delivery system to predicate device	Ortho MTA has a comparable delivery system to White MTA Material. (Explicit statement: "In addition, Ortho MTA (Mineral Trioxide Aggregate) has a comparable delivery system to White MTA Material.")
Differences do not raise new questions of safety and effectiveness	Bench and biocompatibility testing performed demonstrates that any differences in technological characteristics do not raise any new questions as to safety and effectiveness.
Safe and effective for indicated uses	Concluded as safe, effective, and substantially equivalent to the predicate device.

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

Not applicable/mentioned. The study is described as "bench and biocompatibility testing," not a test set in the context of data for AI.

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

Not applicable/mentioned.

4. Adjudication method for the test set

Not applicable/mentioned.

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 an AI-assisted device.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

The "ground truth" here is effectively the accepted properties and performance of the predicate device (White MTA Material). The new device is compared against these established characteristics through "bench and biocompatibility testing."

8. The sample size for the training set

Not applicable/mentioned. This is not an AI device with a training set.

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

Not applicable/mentioned. This is not an AI device with a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for DO Medical Co, Ltd. The logo consists of the letters "DO" stacked on top of each other in a stylized font. The words "DO Medical Co, Ltd." are written to the right of the logo. The text is in a simple, sans-serif font.

K102575

510(k) Summary

0CT-2 9 2010-

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

Date: 09-02-2010

1. Submission Sponsor

	Submitter
Name	DO Co.,Ltd.
Address	551-1, Yongsan-dong, Yuseong-gu,Daejeon, 305-500, South Korea
Phone	Tel: +82-42-935-8926~9
Fax	Fax: +82-42-936-8927

2. Submission Correspondent

LK Consulting Group 2341 W. Crescent Ave. #3, Anaheim, CA 92801 Priscilla Chung Phone: 714-844-2612 Fax: 714-409-3357 Email: agent.fda@gmail.com

3. Device

· Trade Name: Ortho MTA(Mineral Trioxide Aggregate)
· Common Name: Root filling material
· Classification Name: Root canal filling resin
· Classification regulation: 21 CFR 872.3820
· Product Code: KIF

4. Predicate Device

White MTA Material (K011009), Dentsply International

5. Description:

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6. Indications for use:

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

7. Safety and Effectiveness:

Ortho MTA(Mineral Trioxide Aggregate) has similar physical and biocompatible properties, and demonstrates comparable performance specifications to White MTA Material(Predicate device). In addition, Ortho MTA (Mineral Trioxide Aggregate) has a comparable delivery system to White MTA Material.

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 Ortho MTA (Mineral Trioxide Aggregate) is safe, effective and substantially equivalent to the predicate device.

8. Conclusion

Based on the information provided in this premarket notification, Ortho MTA (Mineral Trioxide Aggregate) is safe, effective and substantially equivalent to the predicate devices as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is likely part of a document or sign.

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

DO Company, Limited C/O Ms. Priscilla Chung LK Consulting Group 2341 West Crescent Avenue, #3 Anaheim, California 92801

UCI 2 9 2010

Re: K102575

Trade/Device Name: Ortho MTA (Mineral Trioxide Aggregate) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: September 8, 2010 Received: September 8, 2010

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 (OS) 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.

h 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):	K102575
---------------------------	---------

OCT 2 9 2010

Device Name: Ortho MTA (Mineral Trioxide Aggregate)

Indications For Use:

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

Prescription Use V (Per 21 CFR 801 Subpart D)

AND

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE DED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:	K102575

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.