(154 days)
Not Found
No
The description focuses on the material properties and physical function of a root canal sealer, with no mention of AI/ML, image processing, or data-driven analysis.
Yes
The device is a root canal sealer that provides permanent sealing of root canals, which is a therapeutic function to treat and prevent further issues in the root canal.
No
The device description clearly states its purpose is for "complete and permanent sealing of root canals" and describes it as a "root canal sealer." Its function is to block the root canal by hardening, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a physical material (MTA-based root canal sealer) contained in a syringe with physical components (disposable tip, silicone cap). It hardens by reacting with water, indicating a chemical and physical process, not a software function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide complete and permanent sealing of root canals. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a root canal sealer that hardens within the root canal. This is a material used for treatment, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis. The device's function is purely mechanical and chemical within the tooth.
- Anatomical Site: The anatomical site is "root canals," which are internal structures of the tooth, not a source for diagnostic samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
Product codes
KIF
Device Description
DIA-ROOT BIO Sealer is a hydraulic material, and a premixed form that does not require mixing. It blocks the root canal by hardening by reacting with water in the oral cavity. It is contained in a waterblocked syringe and corresponds to ISO 6876:2012, Dentistry-Root canal sealing materials. DIA-ROOT BIO Sealer has two models and they are packaged with components; Disposable tip, Silicone cap.
| Model Name | Composition |
|---|---|
| DIA-ROOT BIO Sealer 2.0g | 2.0g syringe 1ea + Disposable tip 20ea + Silicone cap 1ea |
| DIA-ROOT BIO Sealer 0.5g | 0.5g syringe 1ea + Disposable tip 4ea + Silicone cap 1ea |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription / 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)
The performance and biological tests were conducted on the subject device; DIA-ROOT BIO Sealer according to the following 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
The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent to the primary predicate device.
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
June 25, 2020
Diadent Group International Kab Sun Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do, 28161 Republic of Korea
Re: K200175
Trade/Device Name: DIA-ROOT BIO Sealer Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF Dated: March 25, 2020 Received: March 27, 2020
Dear Kab Sun 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
Indications for Use
510(k) Number (if known) K200175
Device Name DIA-ROOT BIO Sealer
Indications for Use (Describe)
DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
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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3
510(k) Summary (K200175)
This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of 21 CFR 807.92.
1. Application Information
| Date Prepared | Jun 24, 2020 |
|---|---|
| Company Name and Address | DiaDent Group International |
| 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 |
2. Device Information
| 510(k) Number | K200175 |
|---|---|
| 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 Sealer |
3. Primary Predicate Device
| 510(k) Number | K170950 |
|---|---|
| Applicant | Vericom Co., Ltd. |
| Device Name | Well-Root ST |
| Regulation Number | 21 CFR 872.3820 |
| Product Code | KIF |
| Device Class | II |
4. Device Description
DIA-ROOT BIO Sealer is a hydraulic material, and a premixed form that does not require mixing. It blocks the root canal by hardening by reacting with water in the oral cavity. It is contained in a waterblocked syringe and corresponds to ISO 6876:2012, Dentistry-Root canal sealing materials. DIA-ROOT BIO Sealer has two models and they are packaged with components; Disposable tip, Silicone сар.
| Model Name | Composition |
|---|---|
| DIA-ROOT BIO Sealer 2.0g | 2.0g syringe 1ea + Disposable tip 20ea + Silicone cap 1ea |
| DIA-ROOT BIO Sealer 0.5g | 0.5g syringe 1ea + Disposable tip 4ea + Silicone cap 1ea |
4
5. Indications for Use
DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
6. Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and primary predicate device.
7. Non-Clinical Performance Data
The performance and biological tests were conducted on the subject device; DIA-ROOT BIO Sealer according to the following 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
The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent to the primary predicate device.
8. Technological Characteristics
The subject device, DIA-ROOT BIO Sealer has similar characteristics to the primary predicate device, Well-Root ST.
First, the indications for use of the subject device and primary predicate device is to seal root canal permanently. Our indications for use is more detailed than the predicate device, but it does not contain new indications.
Second, both the subject device and primary predicate device are premixed hydraulic materials, and to seal the root canal by hardening with water in the oral cavity. Also, they are contained in a syringe and supplied with disposable tips.
Third, both the subject device and primary predicate device confirm to ISO 6876 and have similar physical and mechanical properties; Flow, Film thickness, Solubility, Radio-opacity. Also, they are biocompatible.
Finally, they are supplied non-sterile state and have 2 years shelf-life.
The raw materials composition of the subject device is slightly different from the primary predicate device. However, the main material, Calcium silicate of the subject device is similar to Calcium aluminosilicate compound of the primary predicate device. Also, Zirconium Oxide and Polyethylene glycol are contained in both subject device and primary predicate device. Through the results of bench and biocompatibility tests, this difference does not affect substantial equivalance.
[Comparison table]
| Subject Device | Primary Predicate Device | Discuss | |
|---|---|---|---|
| 510(k) Number | K200175 | K170950 | - |
| Product Code | KIF | KIF | Equivalent |
| Device Class | II | II | Equivalent |
5
DiaDent Group International Product Name: DIA-ROOT BIO Sealer
| Manufacturer | DiaDent Group
International | Vericom Co., Ltd. | - |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DIA-ROOT BIO Sealer | Well-Root ST | - |
| Indications for
Use | DIA-ROOT BIO Sealer is
a MTA (mineral trioxide
aggregate) based root
canal sealer that provides
complete and permanent
sealing of root canals. It
can be used with or
without root canal
obturation materials. | Permanent sealing of root
canal | Equivalent |
| Description | DIA-ROOT BIO Sealer is
a hydraulic material, and a
premixed form that does
not require mixing. It
blocks the root canal by
hardening by reacting with
water in the oral cavity. It
is contained in a water-
blocked syringe and
corresponds to ISO
6876:2012, Dentistry-Root
canal sealing materials. | Well-Root ST is a
convenient premixed
ready-to use composition
which requires the
presence of water to set
and harden. The device is
contained in a plastic
syringe and the system
includes a plunger,
disposable tips, and a
holder. | Equivalent |
| Package Contents | -Syringe
-Disposable tip
-Silicone Cap | -Syringe
-Disposable tip
-Holder | Equivalent |
| Raw Materials | - Calcium Silicate
- Calcium Aluminate
- Ytterbium Trifluoride
- Zirconium Oxide
- Silanamine, 1,1,1-
trimethyl-N-
(trimethylsilyl)-,
hydrolysis products with
silica - Hydroxypropyl
Methylcellulose - Polyethylene glycol 400
- Polyethylene glycol 200
- Sorbitan
- White Mineral Oil- | -Calcium aluminosilicate
compound - Calcium Sulfate
dihydrate - Calcium sodium
phosphosilicate - Zirconium Oxide
- Titanium Dioxide
- Polyethylene glycol
- Polypropylene glycol
- Propylene glycol | The main material,
calcium silicate of
the subject device
is similar to
calcium
aluminosilicate
compound of the
primary predicate
device. Also,
zirconium oxide
and polyethylene
glycol are
contained in both
subject device and
primary predicate
device. Through
the results of bench
and
biocompatibility
tests, this
difference does not
affect substantial
equivalence. |
| | | | |
| Principle of
operation | DIA-ROOT BIO Sealer is
a premixed form that does
not require mixing, and a
hydraulic material that
hardens by reacting water.
Also, it blocks the root
canal by hardening by
reacting with water in the
oral cavity. It is contained
in a water-blocked syringe
and is supplied with
disposable tips and
silicone caps. | Well-Root ST is a
convenient premixed
ready-to-use injectable
white hydraulic cement
paste developed for
permanent root canal
filling and sealing
applications. Well-Root
ST is an insoluble,
radiopaque material which
sets and hardens with
moisture providing from
dentin tubules during
hydration reaction. Well-
Root ST is packaged in a
pre-loaded syringe and is
supplied with disposable
tips. | Equivalent |
| Performance
Standard
Conformance | Conformed ISO 6876 | Conformed ISO 6876 | Equivalent |
| Physical and
Mechanical
properties | -Flow: Not less than 17
mm
-Film thickness: Not more
than 50 µm
-Solubility: Not more than
3 %
-Radio-opacity: Not less
than 3 mm | -Flow: Not less than 17
mm
-Film thickness: Not more
than 50 µm
-Solubility: Not more than
3 %
-Radio-opacity: Not less
than 3mm | Equivalent |
| Biocompatibility | Biocompatible | Biocompatible | Equivalent |
| Use | Prescription / Hospital | Prescription / Hospital | Equivalent |
| Period of use | Permanent | Permanent | Equivalent |
| Sterility | Non-sterile | Non-sterile | Equivalent |
| Shelf-life | 2 years | 2 years | Equivalent |
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9. Conclusions
Based on the above information and all data provided in this submission, the subject device is substantially equivalent to the legally marketed device identified in this submission.