TRC-PASTE

K133716 · Km Corporation · KIF · Apr 9, 2014 · Dental

Device Facts

• Record ID: K133716
• Device Name: TRC-PASTE
• Applicant: Km Corporation
• Product Code: KIF · Dental
• Decision Date: Apr 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TRC-Paste is a biocompatible temporary root canal sealer for use in the treatment of root canals, or following pulpectomy, or for apexegenesis or apexification, and for the tip filling of prepared, treated root canals at the time of final filling with gutta- percha.

Device Story

TRC-Paste is a pre-mixed, calcium hydroxide and polypropylene glycol 2000-based temporary root canal filling material. Supplied in a plastic syringe with plunger, disposable tips, rubber, protective cap, and indo stop. Used by dental professionals in clinical settings for root canal therapy, apexogenesis, apexification, and final filling procedures. Constant flow properties facilitate injection into the canal. Provides temporary sealing and filling functionality to support endodontic treatment outcomes.

Clinical Evidence

Bench testing only. Properties tested include radiopacity and flowability (ISO 6876), cytotoxicity (ISO 10993-5), implantation (ISO 10993-6), short-term systemic toxicity (ISO 10993-11), and shelf life (ASTM F1980-07). All results met preset criteria.

Technological Characteristics

Pre-mixed paste containing calcium hydroxide and polypropylene glycol 2000. Delivered via plastic syringe system. Tested per ISO 6876 (radiopacity, flowability), ISO 10993 (biocompatibility), and ASTM F1980-07 (shelf life).

Indications for Use

Indicated for patients requiring temporary root canal sealing, pulpectomy follow-up, apexogenesis, apexification, or tip filling of prepared root canals during final gutta-percha filling.

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

• Metapex by Meta Dental Co. (K032603)

Submission Summary (Full Text)

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# 510(k) Summary

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

Date: 04/09/2014

#### 1. Applicant / Submitter:

KM Corporation 727 , Seoun-ro, Miyang-myeon, Anseong-si, Gyeonggi-do, 456-843, Republic of Korea

Tel: [phone] Fax: [phone]

#### 2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 9283 1 Fax: [phone] Phone: [phone] Email: [e-mail]

#### 3. Device:

| Proprietary Name: | TRC-Paste |
|------------------------------|---------------------------------------|
| Common Name: | Temporary Root Canal Filling Material |
| Classification Name: | Root Canal Filling Resin |
| Classification: | Class II, 21 CFR 872.3820 |
| Classification Product Code: | KIF |

#### 4. Predicate Device:

Metapex by Meta Dental Co. (K032603)

#### 5. Device Description:

TRC-Paste is an immediately available pre-mixed root canal filling material based on Calcium hydroxide and Polypropylene Glycol 2000.

This pre-mixed temporary filling material maintains a constant flow, which makes it easy to inject into the canal. Depending on apicoectomy or infected root canal therapies, it can be

1

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used as a temporary root canal filling material. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, a rubber, a protective cap, an indo stop and a holder for direction control of the tip.

#### 6. Intended Use:

TRC-Paste is a biocompatible temporary root canal sealer for use in the treatment of root canals, or following pulpectomy, or for apexegenesis or apexification, and for the tip filling of prepared, treated root canals at the time of final filling with gutta- percha.

#### 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 - Radiopacity, Flowability
- ISO 10993-5 Cytotoxicity
- * ISO 10993-6 Implantation
- · ISO 10993-11 Short-term systemic toxicity(Oral)
- · ASTM F1980-07 Shelf life test
- · Other bench testing Appearance, volume, and packaging tests

#### 8. Substantial Equivalence

The TRC-paste is substantially equivalent to the predicate device described herein with respect to intended use, device design, main raw material, accessory components, and delivery method.

The difference is the compositions of some additives: however, the biocompatibility and the performance testing results show that this difference does not raise issues in safety and effectiveness.

#### 9. Conclusion:

.

Based on the testing results, KM Corporation concludes that the TRC-Paste is substantially equivalent to predicate device.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines extending from its body, resembling wings or feathers.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

April 9, 2014

KM Corporation C/O Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 East Chapman Avenue. Suite 110 Fullerton. CA 92833

Re: K133716

Trade/Device Name: TRC-Paste Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: January 13, 2014 Received: January 15, 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner - S

Erin I. Keith, M.S. Acting Division 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) K133716

### Device Name TRC-Paste

## Indications for Use (Describe)

TRC-Paste is a biocompatible temporary root canal sealer for use in the treatment of root canals, or for apexegenesis or apexification, and for the tip filling of prepared, treated root canals at the time of final filling with gutts.

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

> Prescription Use (Parl 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.

Image /page/4/Figure/11 description: This image shows a document with the heading "FOR FDA USE ONLY". It indicates the concurrence of the Center for Devices and Radiological Health (CDRH). The document includes a signature, identified as "Sheena A. Green-S", and a date and time stamp of "2014.04.09 11:03:10 -04'00'". The form number "FORM FDA 3881 (9/13)" and page number "Page 1" are also visible.