ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)

K112078 · Maruchi · KIF · Mar 19, 2012 · Dental

Device Facts

• Record ID: K112078
• Device Name: ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
• Applicant: Maruchi
• Product Code: KIF · Dental
• Decision Date: Mar 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A root-end filling material For the repair of root canals as an apical plug during apexification For repair of root perforations during root canal therapy As a consequence of internal resorption As a pulp capping material For the filling of pulpotomy of deciduous tooth

Device Story

ENDOCEM MTA is a mineral trioxide aggregate root canal filling material used by dentists for vital pulp therapies and endodontic repairs. It acts as a barrier to prevent secondary infection and pulp irritation. The material is applied directly to the site of treatment (pulp, root canal, or perforation) by a clinician. It functions as a biocompatible filling agent that sets to provide a seal. The device benefits patients by facilitating tooth preservation through pulp capping and root repair procedures.

Clinical Evidence

Bench testing only. The device was evaluated for physical properties including setting time, solubility, dimensional change, and radiopacity in accordance with ISO 6876 standards. All results met the established test criteria.

Technological Characteristics

Mineral Trioxide Aggregate (MTA) root canal filling material. Physical properties tested per ISO 6876 (setting time, solubility, dimensional change, radiopacity). Biocompatible material.

Indications for Use

Indicated for dental patients requiring root-end filling, apical plug during apexification, repair of root perforations, treatment of internal resorption, pulp capping, or pulpotomy of deciduous teeth.

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

• MTA MATERIAL (K981620)

Submission Summary (Full Text)

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# 510(k) Summary

K11207

MAR 1 9 2012

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

#### Date: 07/15/2011

#### 1. Submission Sponsor

| | Submitter |
|--------------|------------------------------------------------------------------------------------------------------------------|
| Name | MARUCHI |
| Address | 1720-26 Medical Industry Complex Bldg. No. 2-208,<br>Taejang-dong, Wonju-si, Gangwon-do, 220-120, South<br>Korea |
| Phone<br>Fax | Tel: [phone]<br>Fax: [phone] |

# 2. Submission Correspondent

LK Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Phone: [phone] Fax: [phone] Email: [e-mail]

#### 3. Device

- · Trade Name: ENDOCEM 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

MTA MATERIAL (K981620), Dentsply International

## 5. Description:

This product is designed for vital pulp therapies like direct pulp capping treatment. It effectively prevents secondary infection as well as pulp irritation.

510(k) Submission

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# 6. Indications for use:

- · A root-end filling material
- · For the repair of root canals as an apical plug during apexification
- · For repair of root perforations during root canal therapy
- · As a consequence of internal resorption
- As a pulp capping material
- · For the filling of pulpotomy of deciduous tooth

## 7. Safety and Effectiveness:

ENDOCEM MTA (Mineral Trioxide Aggregate) has similar physical and biocompatible properties, and demonstrates comparable performance specifications to MTA MATERIAL (Predicate device). In addition, ENDOCEM MTA (Mineral Trioxide Aggregate) has a comparable delivery system to 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 ENDOCEM MTA (Mineral Trioxide Aggregate) is safe, effective and substantially equivalent to the predicate device.

## 8. Physical Characteristics

The following properties were tested for the device according to ISO 6876 and all the results met the test criteria.

- ISO 6876 Setting time, Solubility, Dimensional change following setting and Radiopacity
#### 9. Conclusion

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

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.

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

MAR 1 9 2012

MARUCHI C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group 951 Starbuck Street, Unit J Fullerton, California 92833

Re: K112078

Trade/Device Name: ENDOCEM MTA (Mineral Trioxide Aggregate) Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: February 22, 2012 Received: February 28, 2012

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 r reaso be advised a determination that your device complies with other requirements nfour that I Drivial 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 (reporting of incured 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), n you acon bttp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices prodoc go to might to the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Those pression" (21CFR Part 807.97). For questions regarding the reporting of promarket netification of 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 I ou may obtain other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours,

Nh fr-

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):

Device Name: ENDOCEM MTA (Mineral Trioxide Aggregate)

# Indications for Use:

- · A root-end filling material
- · For the repair of root canals as an apical plug during apexification
- · For repair of root perforations during root canal therapy
- · As a consequence of internal resorption
- As a pulp capping material
- · For the filling of pulpotomy of deciduous tooth

Prescription Use ﺮ (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: K112078