ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)

K102575 · Do Co., Ltd. · KIF · Oct 29, 2010 · Dental

Device Facts

• Record ID: K102575
• Device Name: ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
• Applicant: Do Co., Ltd.
• Product Code: KIF · Dental
• Decision Date: Oct 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Ortho MTA is a mineral trioxide aggregate material used by dentists/endodontists for root canal therapy and related endodontic repairs. It functions as a root canal filling and repair material; applied clinically to seal root canals, perforations, or pulp exposures. It provides a biocompatible barrier to support healing and prevent leakage in the root canal system. It is a manual-use dental material; no electronic or automated components.

Clinical Evidence

Bench testing only; no clinical data provided. Safety and effectiveness established through comparative bench and biocompatibility testing against the predicate device.

Technological Characteristics

Mineral Trioxide Aggregate (MTA) root canal filling material. Formulated for physical properties and setting requirements necessary for endodontic use. Biocompatible dental material. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring endodontic procedures including orthograde root canal filling, repair of root perforations (from therapy or internal resorption), apical plugging for apexification, root end filling, and pulp capping.

Regulatory Classification

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.

Predicate Devices

• White MTA Material (K011009)

Submission Summary (Full Text)

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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,<br>Daejeon, 305-500, South Korea |
| Phone | Tel: [phone]~9 |
| Fax | Fax: [phone] |

#### 2. Submission Correspondent

LK Consulting Group 2341 W. Crescent Ave. #3, Anaheim, CA 92801 Priscilla Chung Phone: [phone] Fax: [phone] Email: [e-mail]

## 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:

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.

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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

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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.

ל

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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 [phone] or [phone] 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 |