(227 days)
- 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
The raw materials of the ENDOCEM Zr are Natural Pure Cement and Zirconium dioxide, and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and is used in a putty form which gradually hardens in the oral environment.
The acceptance criteria for the ENDOCEM Zr device and the study that proves it meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Property Tested) | Standard Referenced | Preset Test Criteria | Reported Device Performance |
|---|---|---|---|
| Visual Appearance | ISO 6876 | Not explicitly detailed | "All the test results met the preset test criteria." |
| Packaging | ISO 6876 | Not explicitly detailed | "All the test results met the preset test criteria." |
| Setting Time | ISO 6876 | Not explicitly detailed | "All the test results met the preset test criteria." |
| Solubility | ISO 6876 | Not explicitly detailed | "All the test results met the preset test criteria." |
| Radiopacity | ISO 6876 | Not explicitly detailed | "All the test results met the preset test criteria. Subject device has higher Radiopacity still maintaining biocompatibility." |
| Cytotoxicity | ISO 7405 | Not explicitly detailed for device | "All the test results met the preset test criteria." |
| Maximization test for delayed hypersensitivity | ISO 10993-10 | Not explicitly detailed | "All the test results met the preset test criteria." |
| Acute Systemic Toxicity | ISO 10993-11 | Not explicitly detailed | "All the test results met the preset test criteria." |
| Capacity (Other bench testing) | Not specified | Not explicitly detailed | "All the test results met the preset test criteria." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample sizes used for the non-clinical performance tests. The data provenance is also not explicitly stated beyond the tests being conducted based on ISO standards. Since these are bench tests on materials, it's implied to be laboratory-generated data, not human patient data, and therefore does not have a country of origin in the typical sense for clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the data provided. The performance data presented are for non-clinical bench tests (e.g., physical and biocompatibility properties) of a dental material, not for an AI/CADe device or a study involving expert interpretation of patient data. Therefore, there is no "ground truth" established by human experts in the context of image interpretation or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable as the study involved non-clinical bench testing of material properties, not a clinical study requiring adjudication of interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The submission describes the premarket notification for a dental material (ENDOCEM Zr), not an AI-assisted device. Therefore, no MRMC study or AI assistance effect size is discussed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the submission is for a dental material, not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance data is based on the objective measurements and assessments defined by the referenced ISO standards (e.g., ISO 6876 for physical properties, ISO 7405 for cytotoxicity). The criteria for "passing" or "meeting" the standard are inherent to the standard methods themselves.
8. The Sample Size for the Training Set
This information is not applicable. The device is a dental material, not a machine learning model, so there is no training set in the context of AI.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for a machine learning model.
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K13304a
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. Submission Applicant / Submitter:
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: | ENDOCEM Zr |
|---|---|
| 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) (KI 12078) by MARUCHI
5. Device Description:
The raw materials of the ENDOCEM Zr are Natural Pure Cement and Zirconium dioxide, and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and is used in a putty form which gradually hardens in the oral environment.
1
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6. 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
7. Performance Data(Non-Clinical):
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 Maximization test for delayed hypersensitivity
- · ISO 10993-11 Acute systemic toxicity
- · Other bench testing Capacity
8. Substantial Equivalence
ENDOCEM Zr has similar physical and biocompatible properties, and demonstrates comparable performance specifications to ENDOCEM MTA (Predicate device). In addition, ENDOCEM Zr has a comparable delivery system to the ENDOCEM MTA. The predicate device contains Bismuth Oxide for Radiopacity; whereas, the ENDOCEM Zr contains zirconia oxide instead of bismuth oxide. With the zirconia oxide, the subject device has higher Radiopacity still maintaining biocompatibility.
The results of bench and biocompatibility testing performed demonstrate that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that ENDOCEM Zr is substantially equivalent in safety and effectiveness to the predicate device.
9. Conclusion:
Based on the testing results, MARUCHI concludes that the ENDOCEM Zr is substantially equivalent in safety and effectiveness to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2014
Maruchi c/o Ms. Priscilla Chung LK Consulting Group USA, Incorporated 2651 E. Chapman Avenue, Suite 110 Fullerton, CA 92833
Re: K133042
Trade/Device Name: ENDOCEM Zr Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filing Resin Regulatory Class: II Product Code: KIF Dated: April 9, 2014 Received: April 16, 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/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
MarySBunner-s
Erin I. Keith, M.S. Acting 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) KI33042
.
Device Name ENDOCEM Zr
Indications for Use (Describe)
· 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
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
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Form FDA 3881 (9/13)
PSC Publishing Servaces (191) 413-6740
§ 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.