(239 days)
Not Found
No
The device description and performance studies focus on the material properties and biological compatibility of a hydraulic product for dental procedures, with no mention of AI or ML.
Yes
The device is used for therapeutic dental procedures such as pulp capping, repair of root perforation, repair of root resorption, root end filling, apexification, and pulpotomy.
No
The device is a dental material used for therapeutic purposes like pulp capping, root perforation repair, and apexification, not for diagnosing conditions.
No
The device description explicitly states it is a "hydraulic product that hardens by reacting with water" and is packaged with physical components (Cap & Body, Mixing pad, and Spatula), indicating it is a physical material, 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 the device being used directly on the patient's teeth for procedures like pulp capping, root repair, and apexification. This is a therapeutic or restorative use, not a diagnostic one.
- Device Description: The description focuses on the material's properties (hydraulic, hardens with water) and its packaging for direct application in dental procedures.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, or tissue) to provide diagnostic information. IVDs are designed to perform tests in vitro (outside the body) to diagnose conditions.
Therefore, DIA-ROOT BIO MTA is a dental material used for therapeutic and restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
KIF
Device Description
The subject device, 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.
Package Composition: 0.5g cap & body 1ea + Mixing pad 1ea (5 Sheet/Bundle) + Spatula 1ea
Components:
- Cap & Body: It stores the contents.
- Mixing pad: It is a pad used for mixing distilled water and the product.
- Spatula: It is a spatula used for mixing distilled water and the product.
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
Prescription Use (Part 21 CFR 801 Subpart D) / Hospital
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)
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.
Clinical Performance Data: No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.
Key Results: Based on the information and data provided, 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.
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
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
1
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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Food and Drug Administration
Office of Chief Information Officer
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
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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 |
4
5.4 Device Description
| Package Composition | Composition |
|---|---|
| DIA-ROOT BIO MTA 0.5g | 0.5g cap & body 1ea + Mixing pad 1ea (5 Sheet/Bundle) + Spatula |
| 1ea |
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.
5
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 Predicate
Device | Discuss |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | - | K112046 | - |
| Product code | KIF | KIF | Equivalent |
| Device Class | II | II | Equivalent |
| Applicant | DiaDent Group
International | ANGELUS
INDUSTRIA DE
PRODUCTOS
ODONTOLOGICOS | - |
| Device Name | DIA-ROOT BIO MTA | MTA ANGELUS | - |
| Indications For
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. | - Treatment of
perforations of root
canal and furcation
caused iatrogenically or
by caries lesions
- Via canal treatment of
root perforation due to
internal resorption - Surgical treatment of
root perforation due to
internal resorption - Periapical surgery
with reverse filling - Pulp capping
- Pulpotomy(removal of
affected coronal pulp to
preserve vitality of
remaining pulp tissue)
Apexogenesis(inductio
n of root development
in vital teeth with an
inflamed coronal pulp)
Apexification(induction
of formation of a
mineralized barrier at
the root tip of young | Equivalent |
6
| Description | 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. | permanent teeth with
incomplete root
development and a
necrotic pulp)
MTA Angelus is a
mineral trioxide
aggregate cement used
for root repair during
endodontic treatment,
combining the powder
and liquid produces a
colloidal gel that
solidifies to form a
barrier. | 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)-,hydrol
ysis products with silica
-Hydroxypropyl
methylcellulose | - Tricalcium silicate - Dicalcium silicate
- Tricalcium aluminate
- Calcium oxide
- Bismuth oxide
- Distilled water | The main ingredients
are similar, with some
different ingredients.
However, the results of
biocompatibility and
performance tests
confirm that DIA-
ROOT BIO MTA
similar products are
equivalent. |
| Physical
properties | - 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.