(125 days)
Not Found
No
The device description and performance studies focus on the material properties and physical characteristics of the root canal filling material. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The intended use statement explicitly describes the device's role in the treatment of root canals, including "apexegenesis or apexification" and "tip filling," which are therapeutic interventions.
No
TRC-Paste is described as a "biocompatible temporary root canal sealer" and a "pre-mixed root canal filling material" used in the treatment of root canals, not for diagnosing conditions.
No
The device description clearly states it is a physical material (paste) contained in a syringe with various hardware components (plunger, tips, etc.). It is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material used within the body for treating root canals. This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description details a filling material and its delivery system, again consistent with a therapeutic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) or providing information about a patient's health status or condition based on such analysis.
- Performance Studies: The performance studies focus on properties relevant to a dental filling material (radiopacity, flowability, biocompatibility, shelf life), not diagnostic accuracy metrics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
KIF
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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: +82-31-678-3451 Fax: +82-31-678-3489
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 9283 1 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com
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
1
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 (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.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
4
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.