K Number
K133054
Device Name
ENDOSEAL
Manufacturer
Date Cleared
2014-05-12

(227 days)

Product Code
Regulation Number
872.3820
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- . Repair of perforation - . Root canal filling
Device Description
The raw materials of the ENDOSEAL are Natural Pure Cement, Zirconium dioxide, and Citric acid anhydrous, and the device has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and it is used in a putty form which gradually hardens in the oral environment.
More Information

Not Found

No
The device description and performance studies focus on the material properties and biological compatibility of a dental cement, with no mention of AI or ML.

No
The device is described as a filling material for root canals and for repairing perforations, which are restorative procedures rather than therapeutic ones. It's used to seal and repair, not to treat a disease directly.

No
The device is described as a repair and filling material for root canals, not for diagnosing conditions. Its intended use and description focus on material properties and application for treatment, not detection or assessment of disease.

No

The device description clearly states the device is composed of raw materials (Natural Pure Cement, Zirconium dioxide, and Citric acid anhydrous) and is prepared as a mixture of powder and water, indicating it is a physical substance, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended uses are "Repair of perforation" and "Root canal filling." These are procedures performed directly on the patient's body (in vivo) to treat a condition.
  • Device Description: The device is a material (cement) used in a putty form that hardens in the oral environment. This is a therapeutic material applied to the patient.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.

The device described is a dental material used for endodontic procedures, which are clinical treatments performed directly on the patient.

N/A

Intended Use / Indications for Use

  • Repair of perforation
  • Root canal filling

Product codes

KIF

Device Description

The raw materials of the ENDOSEAL are Natural Pure Cement, Zirconium dioxide, and Citric acid anhydrous, and the device has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and it is used in a putty form which gradually hardens in the oral environment.

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 standard. All the test results met the preset test criteria.

  • ISO 6876 Visual, Packaging, Setting time, Solubility and Radiopacity
  • ISO 7405 Cytotoxicity
  • ISO 10993-10 Skin sensitization, Local Lymph Node Assay, LLNA
  • ISO 10993-11 Acute systemic toxicity
  • Other bench testing Capacity and pH (Saline Extracts)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K112078

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

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

KI33054

MAY 1 2 2014

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: 02/26/2014

Submission Applicant / Submitter: 1.

MARUCHI 2-208, 42-10, Taejanggongdan-gil, Wonju-si. Gangwon-do, 220-962, Republic of Korea

Tel: +82-33-734-0330 Fax: +82-33-746-2804

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92833 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Proprietary Name:ENDOSEAL
Common Name:Root Filling Material
Classification Name:Root Canal Filling Resin
Classification:Class II, 21 CFR 872.3820
Classification Product Code:KIF

4. Predicate Device:

ENDOCEM MTA (Mineral Trioxide Aggregate) (K112078) by MARUCHI

5. Device Description:

The raw materials of the ENDOSEAL are Natural Pure Cement, Zirconium dioxide, and Citric acid anhydrous, and the device has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and it is used in a putty form which gradually hardens in the oral environment.

1

1

દ. Intended Use:

  • . Repair of perforation
  • . Root canal filling

Performance Data(Non-Clinical): 7.

The following properties were tested based on the referenced standard. All the test results met the preset test criteria.

  • ISO 6876 Visual, Packaging, Setting time, Solubility and Radiopacity
  • ISO 7405 Cytotoxicity
  • ISO 10993-10 Skin sensitization, Local Lymph Node Assay, LLNA
  • ISO 10993-11 Acute systemic toxicity
  • · Other bench testing Capacity and pH (Saline Extracts)

8. Substantial Equivalence

ENDOSEAL has similar physical and biocompatible properties, and demonstrates comparable performance specifications to ENDOCEM MTA (Mineral Trioxide Aggregate). In addition. ENDOSEAL has a comparable delivery system to ENDOCEM MTA. In comparison, ENDOSEAL contains Zirconium dioxide and Citric acid anhydrous, but Bismuth Trioxide, which is in ENDOCEM MTA, is not present in ENDOSEAL. The results of bench and biocompatibility testing performed demonstrate that this difference does not raise any new questions as to safety and effectiveness. Therefore, it is concluded that ENDOSEAL is substantially equivalent in safety and

effectiveness to the predicate device.

9. Conclusion:

Based on the testing results, MARUCHI concludes that the ENDOSEAL is substantially equivalent in safety and effectiveness to the predicate device.

2

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May 12, 2014

MARUCHI C/O Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, CA 92833

Re: K133054

Trade/Device Name: ENDOSEAL Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: February 26, 2014 Received: March 4, 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 10 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.

Public Health Service

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

3

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/Resourcesfor You/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.gov/MedicalDevices/Resourcesfor You/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

510(k) Number (if known) K133054

Device Name ENDOSEAL

Indications for Use (Describe)

  • · Repair of perforation
    · Root canal filling

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

[x] Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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