(48 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of a calcium hydroxide paste, with no mention of AI or ML.
No
The device is described as an ointment material that fills the root canal and is used as a temporary root canal filling material, indicating it is a dental material, not a therapeutic device.
No
This device is a material used for temporary root canal filling, not a device that provides diagnostic information about a patient's condition.
No
The device description clearly states it is a "calcium hydroxide paste with barium sulfate," which is a physical material, not software. The performance studies also focus on physical properties and biocompatibility of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to temporarily fill the root canal for various dental procedures. This is a direct application within the body for therapeutic or restorative purposes.
- Device Description: It's a calcium hydroxide paste used as a temporary root canal filling material. This is a material placed inside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality. This device does not involve the analysis of such specimens.
The device described is a dental material used in a clinical setting for direct application within the patient's body.
N/A
Intended Use / Indications for Use
Aqueous ointment material that temporarily fills the root canal for the following indications: Apexification Temporary root filling Root canal filling for primary teeth Vital pulpotomy Temporary pulp capping
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
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
Not Found
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 Root Canal Sealing materials
-ISO 7405 Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
-ISO 10993-1 Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process
-ISO 10993-3 Biological Evaluation of Medical Devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
-ISO 10993-5 Biological evaluation of medical devices - Part 5. Tests for in vitro Cytotoxicity
-ISO 10993-10 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-ISO 10993-11 10993-11 - Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
The following Performance tests were conducted.
- Flowability
- -Film thickness
- Radiopacity
- -Biocompatibility test
Performance test (Physical properties):
| Test | Requirement | Result | Pass/Fail |
|---|---|---|---|
| Flowability | Each disc to have a diameter of not less than 17mm | 18mm (mean value) | Pass |
| Film thickness | No more than 50µm | 23µm (mean value) | Pass |
| Radiopacity | Equivalent to not less than 3mm of Aluminum | Not less than 3mm of Aluminum (approx. 4.1mm) | Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains 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.
March 25, 2021
Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 SOUTH KOREA
Re: K210333
Trade/Device Name: DiaPaste Regulation Number: 21 CFR 872.3820 Regulation Name: Root canal filling resin Regulatory Class: Class II Product Code: KIF Dated: February 25, 2021 Received: February 26, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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
2
Indications for Use
510(k) Number (if known) K210333
Device Name DiaPaste
Indications for Use (Describe) Aqueous ointment material that temporarily fills the root canal for the following indications: Apexification Temporary root filling Root canal filling for primary teeth Vital pulpotomy Temporary pulp capping
| 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
Diadent Group International
Special 510(k) Summary
1 Application Information
| Date Prepared: | 01 Feb, 2021 |
|---|---|
| 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
| Device Type: | Root Canal Filling Resin |
|---|---|
| Regulation Description: | Root Canal Filling Resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3820 |
| Product Code: | KIF |
| Device Class: | II |
| Device Name: | DIAPASTE |
3 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| Primary Predicate Device | |
|---|---|
| 510(k) Number: | K190091 |
| Applicant: | DiaDent Group International |
| Device Name: | DiaPaste |
| Regulation Number: | 21 CFR 872.3820 |
| Product Code: | KIF |
| Device Class: | II |
4 Device Configuration
Each model configurations of subject device are described as following:
| Model Name | Contents |
|---|---|
| DiaPaste Type A | 1 syringe(2g), 20 disposable tips, 1silicone cap |
| DiaPaste Type B | 1 syringe(2g), 10 disposable tips, 1silicone cap |
| DiaPaste Type C | 1 syringe(2g), 4 disposable tips, 1silicone cap |
| DiaPaste Refill Kit | 1 syringe(2g) |
| DiaPaste Intro Kit | 1 syringe(0.5g), 4 disposable tips 1 silicone cap |
5 Device Description
Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
4
K210333
Diadent Group International
6 Intended Use/Indications for Use
Aqueous ointment material that temporarily fills the root canal for the following indications:
- ·· Apexification
- · Temporary root filling
- • Root canal filling for primary teeth
- • • Vital pulpotomy
- Temporary pulp capping
7 Comparison Table and Discussion
This device compares to the legally marketed devices as follows:
| Reference Predicate Device | Subject Device | ||
|---|---|---|---|
| DiaPaste | DiaPaste(Special 510k) | Discussion | |
| Regulation | |||
| Number: | 21 CFR 872.3820 | 21 CFR 872.3820 | - |
| 510(k) | |||
| Number | K190091 | K210333 | - |
| Indication | |||
| for Use | Aqueous ointment material that | ||
| temporarily fills the root canal for the | |||
| following indications: | |||
| • Apexification | |||
| • Temporary root filling | |||
| • Root canal filling for primary | |||
| teeth | |||
| • Vital pulpotomy | |||
| • Temporary pulp capping | Aqueous ointment material that | ||
| temporarily fills the root canal for the | |||
| following indications: | |||
| • Apexification | |||
| • Temporary root filling | |||
| • Root canal filling for primary teeth | |||
| • Vital pulpotomy | |||
| • Temporary pulp capping | equivalent | ||
| Compositi | |||
| on | -. Polyoxymethylene sorbitan | ||
| monooleate | |||
| -. Polyethylene glycol | |||
| -. Distilled water | |||
| -. Barium sulfate | |||
| -. Zinc oxide | |||
| -. Calcium hydroxide | |||
| -. Calcium carbonate | -. Calcium hydroxide | ||
| -. Titanium dioxide | |||
| -. Zinc oxide | |||
| -. Barium sulfate | |||
| -. Water | |||
| -. Polyether Polyol | |||
| -. Polysorbate (Tween80) | - | ||
| Period of | |||
| Use | Temporary | ||
| (remains in the body for 29 days or | |||
| less) | Temporary | ||
| (remains in the body for 29 days or | |||
| less) | equivalent | ||
| Physical | |||
| properties | Conformed to ISO 6876 |
- Flowability
- Film Thickness
- Radio-opacity | Conformed to ISO 6876
- Flowability
- Film Thickness
- Radio-opacity | equivalent |
| Biocompa
tibility | Biocompatible - Cytotoxicity
- Sensitization
- Acute Systemic toxicity
- Oral Mucosa irritation
- Genetoxicity-Bacterial Reverse
Mutation - Genetoxicity- Micronucleus test | Biocompatible
- Cytotoxicity
- Sensitization
- Irritation Test
- Genotoxicity Test
- Acute Systemic Toxicity Test
- Sub chronic Toxicity test
- Implantation Test | equivalent |
| Package
Contents | •Syringe
•Disposable Tip
•Silicone Cap | •Syringe
•Disposable Tip
•Silicone Cap | - |
5
Differences
-Composition
| Composition | ||
|---|---|---|
| Reference Predicate Device | Subject Device | Discussion |
| • Polyoxymethylene sorbitan | ||
| monooleate | ||
| • Polyethylene glycol | ||
| • Distilled water | ||
| • Barium sulfate | ||
| • Zinc oxide | ||
| • Calcium hydroxide | ||
| • Calcium carbonate | • Calcium hydroxide | |
| • Titanium dioxide | ||
| • Zinc oxide | ||
| • Barium sulfate | ||
| • Water | ||
| • Polyether Polyol | ||
| • Polysorbate (Tween80) | Raw materials except Titanium dioxide is the same as | |
| the before medical device. The reason for this change | ||
| is product improvement due to consumer request. | ||
| and the biocompatibility of subject device was | ||
| confirmed by biological safety study. |
8. 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 | Root Canal Sealing materials |
|---|---|
| -ISO 7405 | Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry |
| [Including: Amendment 1 (2013)] | |
| -ISO 10993-1 | Biological evaluation of medical devices - Part 1:Evaluation and testing within a |
| risk management process | |
| -ISO 10993-3 | Biological Evaluation of Medical Devices - Part 3: Tests for genotoxicity, |
| carcinogenicity and reproductive toxicity | |
| -ISO 10993-5 | Biological evaluation of medical devices - Part 5. Tests for in vitro Cytotoxicity |
| -ISO 10993-10 | Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin |
| Sensitization | |
| -ISO 10993-11 | 10993-11 - Biological Evaluation of Medical Devices - Part 11: Tests for |
| Systemic Toxicity |
The following Performance tests were conducted.
- Flowability
- -Film thickness
- Radiopacity
- -Biocompatibility test
Performance test (Physical properties):
| Test | Requirement | Result | Pass/Fail |
|---|---|---|---|
| Flowability | Each disc to have a diameter of not | ||
| less than 17mm | 18mm (mean value) | Pass | |
| Film thickness | No more than 50µm | 23µm (mean value) | Pass |
| Radiopacity | Equivalent to not less than 3mm of | ||
| Aluminum | Not less than 3mm of | ||
| Aluminum (approx. 4.1mm) | Pass |
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9. Conclusion
"Root Canal Filling Materials (model name: DiaPaste)" was compared to "Root Canal Filling Materials (model name: Diapaste) which has similar purpose of use, principle of action, method of use and test specifications. The purpose of use, principle of action, test standard, and method of use were the same as the comparison product, but there were differences in performance, and the raw materials were similar except for some components. In addition, there were no cases of biological side effects reported so far for the licensed product, and the biological safety test results for the applied product were judged as "suitable" for all items. DiaPaste is determined to have a level of biological safety that satisfies risk-benefit analysis based on the clinical use history of similar market products when used according to the intended use and methods of use.