(217 days)
Metapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material. Application : Root canal filling material/Apexification and hard tissue formation/Apexogensis
This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide. The state of the treatment can be confirmed by the radiopacity of iodoform contained. Metapex Plus is used for patients of all ages requiring root canal treatment.
The provided text describes the 510(k) premarket notification for "Metapex Plus," a root canal filling material. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on AI performance or diagnostic accuracy.
Therefore, the provided input does not contain the information requested to describe acceptance criteria and a study proving a device meets them in the context of an AI/human reader performance study.
The information in the document pertains to:
- Device Type: A medical device (root canal filling material), not an AI-powered diagnostic tool.
- Approval Type: 510(k) clearance, which focuses on substantial equivalence to a legally marketed predicate device, primarily through comparing technological characteristics and performance standards (like ISO 6876 for dental materials), rather than clinical efficacy trials or AI performance evaluations.
- Testing: Non-clinical testing for performance (e.g., flowability, radiopacity) and biocompatibility, as well as shelf-life testing, all against established ISO standards for dental materials. There is no mention of a test set, training set, ground truth established by experts, or human reader performance studies.
To answer your request, if this were an AI-powered diagnostic device, the following information would be expected but is NOT present in the provided text:
- Table of Acceptance Criteria and Reported Device Performance: This would define metrics like sensitivity, specificity, AUC, or F-score and specify threshold values for acceptance.
- Sample Size and Data Provenance: For an AI study, this would detail the number of images/cases in the test set, their origin (e.g., country, hospital), and whether the data was collected retrospectively or prospectively.
- Number and Qualifications of Experts for Ground Truth: This would specify how many radiologists (or other medical specialists) with what level of experience established the ground truth.
- Adjudication Method: How discrepancies between experts were resolved (e.g., 2+1 agreement, majority vote).
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Whether human readers were tested with and without AI assistance, and the effect size of the AI's improvement on human performance.
- Standalone Performance: The AI algorithm's performance without human interaction.
- Type of Ground Truth: How the definitive diagnosis was established (e.g., pathology, long-term outcomes, expert consensus).
- Training Set Sample Size: The number of cases used to train the AI model.
- Training Set Ground Truth Establishment: How the labels for the training data were determined.
In summary, the provided FDA 510(k) clearance letter and summary discuss a dental material's substantial equivalence based on material properties and non-clinical testing against ISO standards, not a study evaluating the performance of an AI-powered diagnostic device or human-in-the-loop performance.
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April 14, 2021
Meta Biomed Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K202617
Trade/Device Name: Metapex Plus Regulation Number: 21 CFR 872.3820 Regulation Name: Root canal filling resin Regulatory Class: Class II Product Code: KIF Dated: April 13, 2021 Received: April 13, 2021
Dear April Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202617
Device Name Metapex Plus
Indications for Use (Describe)
Metapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
· Application : Root canal filling material/Apexification and hard tissue formation/Apexogensis
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Submitter
META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea 28161 Email: ef1459@metabiogw.bizmeka.com Phone: +82-43-230-8841 Fax: +82-43-217-1983
Device Information
- Trade Name: Metapex Plus ●
- . Classification Name: Resin, Root Canal Filling
- Product Code: KIF ●
- . Panel: Dental
- . Regulation Number: 21 CFR 872.3820
- . Device Class: Class II
- . Date prepared: 04/09/2021
Predicate Devices:
Primary Predicate
-
K182625, Diapex Plus by DiaDent Group International .
Reference Devices: -
. K973667, Vitapex Pre-Loaded Dental Syringe by Neo Dental Chemical Products Company, Ltd.
Device Description
This product is a calcium hydroxide paste material that is temporarily filled into the root canal. It is pre-mixed in a syringe for convenient delivery in the root canal. When applied to root canal, it is alkaline by calcium hydroxide.
The state of the treatment can be confirmed by the radiopacity of iodoform contained. Metapex Plus is used for patients of all ages requiring root canal treatment.
Indication for Use
Metapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
- . Application: Root canal filling material/Apexification and hard tissue formation/Apexogensis
Official Correspondent
Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
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Summary of Technological Characteristics:
The subject device and the primary predicate have the similar indications, principle of operation, technological characteristics and materials. They encompass the same range of physical and chemical properties. The subject device and predicate devices are packaged in similar material and use similar methods of application.
Compared to the primary predicate, the flowability Radiopacity, and material are different with the subject device.
however, the flow of dental root canal filling material shall be more than 17mm in accordance with ISO 6876: 2012 test method and the subject device's flowability value meet the ISO 6876 requirements. Therefore, this difference doesn't impact the clinical performance of the product and substantial equivalence.
Also, the Radio-opacity of dental root canal filling material shall have a radio opacity equivalent to not less than 3 mm of aluminum in accordance with ISO 6876: 2012 test method and the subject device's Radio-opacity value meet the ISO 6876 requirements. Therefore, this difference doesn't impact the clinical performance of the product and substantial equivalence.
Compared to the predicate devices, some of minor ingredients are different with the subject device. However, the main ingredients of Calcium hydroxide and Iodoform are same and by performing the biological evaluation and testing, biological safety of the subject device was proved and it demonstrates the clinical performance and safety of the subject device. Therefore, although there is difference of raw materials between subject device and predicate devices, it does not affect the clinical performance and safety and the devices are substantial equivalent.
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Manufacturer | META BIOMED CO.,LTD. | DiaDent GroupInternational | NEO DENTAL CHEMICALPRODUCTS CO., LTD. |
| Device Name | Metapex Plus | Diapex Plus | Vitapex |
| 510(k)Number | NA | K182625 | K973667 |
| ClassificationName | resin, root canal filling | resin, root canal filling | resin, root canal filling |
| Product Code | KIF | KIF | KIF |
| RegulationNumber | 21 CFR 872.3820 | 21 CFR 872.3820 | 21 CFR 872.3820 |
| Indications foruse | Metapex Plus is acalcium hydroxide pastewith iodoform, used as atemporary root canalfilling material.Application : Root canalfillingmaterial/Apexificationand hard tissueformation/Apexogensis. | Diapex Plus is a calciumhydroxide paste withiodoform, used as atemporary root canalfilling material.Application : Root canalfillingmaterial/Apexificationand hard tissueformation/Apexogensis. | For use to stimulate the healingprocess due to the mixture ofcalcium hydroxide and iodoformand the induction effect of thesetwo ingredients. Used topromote healing effects and tohelp prevent bacterialcontamination of the canal, asthe two ingredients improved theinduction effect for hard tissueinduction and deposition. To beused as a medicament for the |
| treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha. | |||
| Raw Material | -Calcium hydroxide-Iodoform-Polydimethylsiloxane-Peppermint oil | -Calcium hydroxide-Iodoform-Polydimethylsiloxane-Olive oil | -Calcium hydroxide-Iodoform-Silicone Oil-Inert |
| Principle ofOperation | Calcium-hydroxide based ointment material used to fill the root canal for a certain period of time Filled in a syringe for convenient implantation. | Calcium-hydroxide based ointment material used to fill the root canal for a certain period of time Filled in a syringe for convenient implantation. | Calcium-hydroxide based ointment material used to fill the root canal for a certain period of time Filled in a syringe for convenient implantation. |
| PerformanceStandardConformance | Conformed to ISO 6876 | Conformed to ISO 6876 | Conformed toISO 6876 |
| Flowability | 24mm | 27.5mm | - |
| Radiopacity | 5.4mm | 2.8mm | - |
| Bio-compatibility | Yes | Yes | Yes |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Shelf Life | 2 years | 3 years | 3 years |
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Non-clinical Testing
The following testing was conducted on our subject device:
- . Performance testing such as Appearance, Weight, Packaging according to Manufacturer standard.
- . Performance testing of Flowability, Radio-opacity according to ISO 6876:2012.
- Biocompatibility Tests according to ISO 10993-1:2018, ISO 10993-2:2006, ISO 10993-3:2014, . ISO 10993-5:2009, ISO 10993-6:2016, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2012
- . Shelf Life test: Manufacturer standard tests (Appearance, Packaging), ISO 6876:2012 tests (Flowability, Radio-opacity)
Conclusion:
Based on documentation supplied with this submissions drawn from the testing results demonstrate that the subject device is substantially equivalent to our legally marketed predicate device.
§ 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.