(434 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.
Yes
The device, Diapaste, is an aqueous ointment material that temporarily fills the root canal for therapeutic purposes such as apexification, temporary root filling, and vital pulpotomy, aiming to treat or alleviate dental conditions.
No
Diapaste is a temporary root canal filling material; its intended uses (apexification, temporary root filling, etc.) are therapeutic and restorative, not diagnostic.
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 like flowability, film thickness, and radiopacity.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material that is placed within the body (specifically, the root canal) for therapeutic purposes (filling, capping, apexification).
- Device Description: The description confirms it's a paste used as a temporary root canal filling material.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used to test blood, urine, tissue samples, etc., to detect diseases, conditions, or markers.
- Performance Studies: The performance studies focus on physical properties (flowability, film thickness, radiopacity) and biocompatibility, which are relevant for a material placed in the body, not for a diagnostic test.
Therefore, Diapaste is a medical device, but it falls under the category of a therapeutic or restorative material, not an in vitro diagnostic device.
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
Not Found
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)
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 -ISO 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):
Flowability
Requirement: Each disc to have a diameter of not less than 17mm
Result: 21mm (mean value)
Pass/Fail: Pass
Film thickness
Requirement: No more than 50µm
Result: 45µm (mean value)
Pass/Fail: Pass
Radiopacity
Requirement: Equivalent to not less than 3mm of Aluminum
Result: Not less than 3mm of Aluminum (approx. 5.3mm)
Pass/Fail: 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.
0
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 27, 2020
Diadent Group International Kab Sun, Lee Quality Assurance Manager 16. Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, 28161 KOREA
Re: K190091
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 19, 2020 Received: February 20, 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 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
1
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.
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
Indications for Use
510(k) Number (if known) K190091
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K190091 Diadent Group International
510(k) Summary
1 Application Information
Date Prepared: | March 26, 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
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 | Reference Predicate Device | |
---|---|---|
510(k) Number: | K032605 | K060365 |
Applicant: | Meta Biomed Co., Ltd. | Ivoclar Vivadent |
Device Name: | Metapaste | ApexCal |
Regulation Number: | 21 CFR 872.3820 | 21 CFR 872.3250 |
Product Code: | KIF | EJK |
Device Class: | II | 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, 1 silicone cap |
DiaPaste Type B | 1 syringe(2g), 10 disposable tips, 1 silicone cap |
DiaPaste Type C | 1 syringe(2g), 4 disposable tips, 1 silicone 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
K190091
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:
| | Subject Device | Primary Predicate
Device | Reference Predicate
Device | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | DiaPaste | Metapaste | ApexCal | Discussion |
| Regulation
Number: | 21 CFR 872.3820 | 21 CFR 872.3820 | 21 CFR 872.3250 | |
| 510(k)
Number | K190091 | K032605 | K060365 | - |
| 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 | Metapaste is a
biocompatible root canal
sealer used for the
temporary filling of root
canals after endodontic
surgery. Metapaste can be
used on its own and for
vital pulpectomies in
decidious teeth.
Metapaste is intended for
use by qualified healthcare
personnel trained in its
use. | ApexCAL is a Calcium
Hydroxide paste that has a
creamy consistency and is
suitable for several
indications including:
- Temporary disinfectant
dressings in the obturation
of root canals; - Indirect pulp capping or
management of deep
caries lesions; or - Direct pulp capping. | |
| Composition | - Calcium hydroxide
- Calcium carbonate
- Zinc oxide
- Barium sulfate
- Water
- Polyethylene glycol
400 - Polysorbate
(Tween80) | Calcium Hydroxide
Barium Sulfate
Poly propylene glycol | - Calcium hydroxide - Bismuth carbonate
- Zinc oxide
- Polyethylene glycol
- glycerin
- Water | |
| Period of
Use | Temporary
(remains in the body for
29 days or less) | Temporary | Temporary | equivalent |
| Physical
properties | Conformed to ISO 6876 - Flowability
- Film Thickness
- Radio-opacity | Conformed to ISO 6876 | | equivalent |
| Biocompa
tibility | Biocompatible - Cytotoxicity
- Sensitization
- Acute Systemic toxicity
- Oral Mucosa irritation
- Genetoxicity-
Bacterial Reverse
Mutation - Genetoxicity-
Micronucleus
test | Biocompatible
Freedom from toxicity per
ISO/TR 7405 Agar
diffusion test | Biocompatible | equivalent |
| Package
Contents | • Syringe
• Disposable Tip
• Silicone Cap | • 2.2g paste in a syringe
• Disposable tips
• One ring rotator for the
direction control of the tip | • 2 syringes 2.5g each
• 15 application tips | - |
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K190091
Diadent Group International
Differences
- Indication For Use
| DiaPaste
(K190091) | Primary Predicate Device
(Metapaste, K032605) | Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | Metapaste is a
biocompatible root canal
sealer used for the
temporary filling of root
canals after endodontic
surgery.
Metapaste can be used on
its own and for vital
pulpectomies in decidious
teeth.
Metapaste is intended for
use by qualified healthcare
personnel trained in its use. | Diapaste and Primary predicate device
(Metapaste) can be used for apexification &
pulpectomy technique for root canal
treatment as temporary root canal filling
materials. The Indication for Use of Subject
and predicate devices has same contents.
In the DiaPaste's Indication for Use, there are
contents of Pulpotomy and Temporary pulp
capping that is not found in Indication of use
of Metapaste. It is a technique commonly
used of temporary root canal fillings and as
such does not affect the equivalence of
Indication of subject and predicate devices. |
-Composition
| Subject Device | Primary Predicate Device
(K032605) | Reference Predicate
Device(K060365) | Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - Calcium hydroxide
- Calcium carbonate
- Zinc oxide
- Barium sulfate
(Radiopaque) - Water
- Polyethylene glycol 400
- Polysorbate (Tween80) | Calcium Hydroxide
Barium Sulfate
(Radiopaque)
Poly propylene glycol | - Calcium hydroxide - Bismuth carbonate
- Zinc oxide
- Polyethylene glycol
- glycerin
- Water | The main ingredient of
subject and predicate
devices is Calcium
Hydroxide. and the
functions of other
additives are similar
(base, Radiopaque,
pH controller,
Stabilizer).
Also, the
biocompatibility of
subject device was
confirmed by
biological safety study. |
6
Diadent Group International
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 | -ISO 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 | 21mm (mean value) | Pass | |
Film thickness | No more than 50µm | 45µm (mean value) | Pass |
Radiopacity | Equivalent to not less than 3mm of | ||
Aluminum | Not less than 3mm of | ||
Aluminum (approx. 5.3mm) | Pass |
9. Conclusion
Based on the above information and all data provided in this submission, including comparison of intended uses, technological characteristics discussion of differences of subject and predicate devices, show that the subject device and the predicate device have similar technical characteristic and chemical composition.
It is demonstrated that the subject device and the legally marketed devices identified in this submission are substantially equivalent.