(239 days)
DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy.
DIA-ROOT BIO MTA is a hydraulic product that hardens by reacting with water. It is designed for the protection of pulp such as direct pulp capping, pulpotomy, and perforation. The subject device is packaged with Cap & Body, Mixing pad, and Spatula.
The provided document is a 510(k) Premarket Notification from the FDA regarding a dental device called "DIA-ROOT BIO MTA". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or "human-in-the-loop" performance with AI.
Therefore, many of the requested criteria (e.g., number of experts, adjudication methods, MRMC studies, AI effect size, training set details) are not applicable to this specific type of device submission and the information available in the document. The document describes a biomaterial (root canal filling resin), not an AI-powered diagnostic or therapeutic device.
Here's an analysis of the available information based on the request:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) for a diagnostic AI. Instead, the "acceptance criteria" for this device, as implied by the FDA 510(k) process, are demonstrating substantial equivalence to a predicate device based on:
- Intended Use: Similar indications for use.
- Technological Characteristics: Similar materials, physical, and mechanical properties.
- Performance Data: Conformance to relevant industry standards and non-clinical bench testing, showing similar safety and effectiveness.
The document reports performance against non-clinical harmonized standards.
| Criteria Type (Implied) | Specific Criteria (from ISO standards & bench testing) | Reported Device Performance | Comments |
|---|---|---|---|
| Physical Properties | ISO 6876:2012 (Dentistry Root canal sealing materials) | Conforms | Includes properties like Setting time, Solubility, Radio-opacity. Stated as "similar" to predicate and "Equivalent" in comparison table. |
| Mechanical Properties | Bench Testing (details not specified) | Conforms | Stated as "similar" to predicate and "Equivalent" in comparison table. |
| Biocompatibility | ISO 7405:2018 (Evaluation of biocompatibility of medical devices used in dentistry) ISO 10993 series (various parts) | Biocompatible | Confirmed via conformance to the listed ISO 10993 standards. Stated as "Biocompatible" and "Equivalent" to predicate. |
| Safety & Effectiveness | Non-clinical bench testing (additional) | Demonstrated | General statement that additional testing demonstrates safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not applicable as there was no "test set" in the context of clinical performance data collection (e.g., patient cases for a diagnostic study). The testing performed was non-clinical bench testing (material properties, biocompatibility).
- The document states: "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This information is not applicable. There was no expert-derived "ground truth" for a clinical test set because no clinical data was collected.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. No clinical test set.
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. DIA-ROOT BIO MTA is a dental material, not an AI or a device that assists human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This is a material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical performance evaluation, the "ground truth" would be established by the harmonized ISO standards themselves (e.g., the specific parameters and methodologies defined in ISO 6876 for setting time, solubility, radiopacity, or the tests for biocompatibility in the ISO 10993 series).
- The study proves the device meets the criteria specified by these international standards for dental materials, not against clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
- This information is not applicable. This is a material, not an AI. No training set was used.
9. How the ground truth for the training set was established
- This information is not applicable. No training set.
Summary of what the document focuses on:
The entire submission is built around demonstrating that "DIA-ROOT BIO MTA" is substantially equivalent to a previously cleared predicate device ("MTA ANGELUS"). This is achieved by comparing their:
- Intended Uses
- Technological Characteristics (composition, physical/mechanical properties)
- Performance (conformance to the same non-clinical ISO standards for dental materials and biocompatibility).
The document explicitly states that no clinical data was collected for this submission. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical bench tests and biocompatibility evaluations conducted according to recognized international standards (ISO 6876, ISO 7405, and various parts of ISO 10993). The "acceptance criteria" are simply the successful demonstration of conformance to these standards and the similarity of the device's properties to the predicate.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2020
Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, 28161 KOREA
Re: K200174
Trade/Device Name: Dia-root Bio Mta Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: August 11, 2020 Received: August 19, 2020
Dear Kab 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 medical devices and radiation-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,
for Srinivas "Nandu" Nandkumar, Ph.D. 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. |
|---|---|
| Indications for Use |
| 510(k) Number (if known) | K200174 |
|---|---|
| Device Name | DIA-ROOT BIO MTA |
| Indications for Use ( Describe ) | DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation.Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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5.0 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
5.1 Application Information
| Date Prepared: | Aug 11, 2020 |
|---|---|
| Company Name and | DiaDent Group International |
| Address: | 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju- |
| si, Chungcheongbuk-do, 28161, Republic of Korea | |
| Contact Person: | Kab Sun Lee |
| Quality Assurance Manager | |
| Phone: +82-43-266-2315 | |
| FAX: +82-43-235-2315 | |
| Email: diadent32@diadent.co.kr |
5.2 Device Information
| Device Type: | Resin, Root Canal Filling |
|---|---|
| Regulation Description: | Root canal filling resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3820 |
| Product Code: | KIF |
| Device Class: | II |
| Device Name: | DIA-ROOT BIO MTA |
5.3 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| 510(k) Number: | K112046 |
|---|---|
| Applicant: | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
| Device Name: | MTA ANGELUS |
| Regulation Number: | 872.3820 |
| Product Code: | KIF |
| Device Class: | II |
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5.4 Device Description
| Package Composition | Composition |
|---|---|
| DIA-ROOT BIO MTA 0.5g | 0.5g cap & body 1ea + Mixing pad 1ea (5 Sheet/Bundle) + Spatula1ea |
The subject device is packaged with the following:
| No. | Component | Description |
|---|---|---|
| 1 | Cap & Body | It stores the contents. |
| 2 | Mixing pad | It is a pad used for mixing distilled water and the product. |
| 3 | Spatula | It is a spatula used for mixing distilled water and the product. |
5.5 Intended Use
DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy.
5.6 Non-Clinical Performance Data
This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:
- ISO 6876:2012, Dentistry Root canal sealing materials
- ISO 7405:2018, Dentistry Evaluation of biocompatibility of medical devices used in dentistry
- ISO 10993-1:2018, Evaluation and testing within a risk management process
- ISO 10993-2:2006, Animal welfare requirements
- ISO 10993-3:2014, Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5:2009, Tests for in vitro cytotoxicity
- ISO 10993-6:2016, Tests for local effects after implantation
- ISO 10993-10:2010, Tests for irritation and skin sensitization
- ISO 10993-11:2017, Tests for systemic toxicity
- ISO 10993-12:2012, Sample preparation and reference materials
Additional non-clinical bench testing demonstrates the safety and effectiveness of the subject device.
5.7 Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.
5.8 Technological characteristics
The subject device, DIA-ROOT BIO MTA has similar characteristics to the predicate device, MTA ANGELUS.
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First, the intend use of the subject device and predicate device is pulp capping and to repair of root perforation.
Second, both the subject device and predicate device are to react with water.
Third, both the subject device and predicate device confirm to ISO 6876 and have similar physical and mechanical properties; Setting time, Solubility, Radio-opacity. Also, they are biocompatible. Finally, they are supplied non-sterile state and have 3 years shelf-life.
The raw materials composition of the subject device is slightly different from the predicate device. However, the main material, Calcium silicate of the subject device is similar to Tricalcium silicate, Dicalcium silicate of the predicate device. Through the results of bench and biocompatibility tests, this difference does not raise any issue of safety and effectiveness.
| Subject Device | Primary PredicateDevice | Discuss | |
|---|---|---|---|
| 510(k) Number | - | K112046 | - |
| Product code | KIF | KIF | Equivalent |
| Device Class | II | II | Equivalent |
| Applicant | DiaDent GroupInternational | ANGELUSINDUSTRIA DEPRODUCTOSODONTOLOGICOS | - |
| Device Name | DIA-ROOT BIO MTA | MTA ANGELUS | - |
| Indications ForUse | DIA-ROOT BIO MTAis used for pulp capping(direct pulp capping orpartial pulpotomy) andrepair of rootperforation. Otherindications for useinclude: repair of rootresorption, root endfilling, apexificationand pulpotomy. | - Treatment ofperforations of rootcanal and furcationcaused iatrogenically orby caries lesions- Via canal treatment ofroot perforation due tointernal resorption- Surgical treatment ofroot perforation due tointernal resorption- Periapical surgerywith reverse filling- Pulp capping- Pulpotomy(removal ofaffected coronal pulp topreserve vitality ofremaining pulp tissue)-Apexogenesis(induction of root developmentin vital teeth with aninflamed coronal pulp)-Apexification(inductionof formation of amineralized barrier atthe root tip of young | Equivalent |
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| Description | DIA-ROOT BIO MTAis a hydraulic productthat hardens by reactingwith water. It isdesigned for theprotection of pulp suchas direct pulp capping,pulpotomy, andperforation. | permanent teeth withincomplete rootdevelopment and anecrotic pulp)MTA Angelus is amineral trioxideaggregate cement usedfor root repair duringendodontic treatment,combining the powderand liquid produces acolloidal gel thatsolidifies to form abarrier. | Equivalent |
|---|---|---|---|
| Package Contents | • Cap & Body• Mixing pad• Spatula | • Cap & Body• Distilled Water• Spoon | - |
| Composition | - Calcium silicate- Zirconium dioxide- Citric acid- Silanamine, 1,1,1-trimethyl-N-(trimethylsilyl)-,hydrolysis products with silica-Hydroxypropylmethylcellulose | - Tricalcium silicate- Dicalcium silicate- Tricalcium aluminate- Calcium oxide- Bismuth oxide- Distilled water | The main ingredientsare similar, with somedifferent ingredients.However, the results ofbiocompatibility andperformance testsconfirm that DIA-ROOT BIO MTAsimilar products areequivalent. |
| Physicalproperties | - Setting time- Solubility- Radiopacity | - Setting time- Solubility- Radiopacity | Equivalent |
| Use | Prescription / Hospital | Prescription / Hospital | Equivalent |
| Period of Use | Permanent | Permanent | Equivalent |
| Sterility | Non-sterile | Non-sterile | Equivalent |
| Shelf-life | 3 years | 3 years | Equivalent |
| Biocompatibility | Biocompatible | Biocompatible | Equivalent |
| Standards | ISO7405 | ISO7405 | - |
5.9 Conclusions
Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance testing demonstrates that the subject device is substantially equivalent to the legally marketed devices identified in this submission.
§ 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.