(252 days)
No
The summary describes a calcium hydroxide paste for root canal filling and lists standard biocompatibility and performance tests. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes.
The device is used as a temporary root canal filling material for therapeutic purposes such as apexification and hard tissue formation.
No
Explanation: The device is a temporary root canal filling material, which is a therapeutic product used for treatment, not for diagnosing a condition.
No
The device description explicitly lists physical components (Syringe, Disposable Tip, Silicon Cap) and the intended use is a physical paste, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary root canal filling material." This is a material used within the body for a therapeutic purpose (filling a root canal), not for examining specimens from the body to provide diagnostic information.
- Device Description: The description lists a syringe, disposable tip, and silicon cap, which are consistent with a material delivery system for a dental procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on material properties and biocompatibility, not diagnostic accuracy.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material. Application : Root canal filling material/Apexification and hard tissue formation/Apexogensis
Product codes
KIF
Device Description
The subject device is packaged with the following:
- Syringe
- Disposable Tip .
- Silicon Cap .
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
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 (relevant test: Flowability, Film Thickness, Radio-opacity), ISO 7405:2008, ISO 10993-1:2009, ISO 10993-3:2014 (relevant tests: Genotoxicity Bacterial Reverse Mutation, Genotoxicity Mouse Lymphoma Assay), ISO 10993-5:2009 (relevant test: Cytotoxicity), ISO 10993-6: 2016 (relevant test: 4 Week Systemic Toxicity), ISO 10993-10:2010 (relevant test: Sensitization), ISO 10993-11:2017 (relevant tests: Acute Systemic Toxicity, Pyrogenicity, 4 Week Systemic Toxicity). Additional non-clinical bench testing demonstrates the substantial equivalence 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 Metrics
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 3, 2019
Diadent Group International Myung Sub Kim Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si, Chungcheongbuk-do, 28161 Republic of Korea
Re: K182625
Trade/Device Name: Diapex Plus Regulation Number: 21 CFR 872.3820 Regulation Name: Root canal filling resin Regulatory Class: Class II Product Code: KIF Dated: April 15, 2019 Received: April 19, 2019
Dear Myung Sub Kim:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Malvina B Eydelman, M.D. Director 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 SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name DIAPEX PLUS
Indications for Use (Describe)
DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material. Application : Root canal filling material/Apexification and hard tissue formation/Apexogensis
| 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
3
Product Name : DIAPEX PLUS
5.0 510(k) Summary
This summary of 510(k) information is submitted in accordance with the requirements of 21 CFR 807.92.
5.1 Application Information
| Date Prepared: | 21st September, 2018 |
|---|---|
| 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: | Myung Sub Kim |
| Quality Assurance Manager | |
| Phone: +82-43-266-2315 | |
| FAX: +82-43-235-2315 | |
| Email: diadent32@diadent.co.kr |
5.2 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: | DIAPEX PLUS |
5.3 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| 510(k) Number: | K973667 | K032603 |
|---|---|---|
| Applicant: | Neo Dental Chemical Products | |
| Co, Ltd. | Meta Biomed Co., Ltd. | |
| Device Name: | Vitapex | Metapex |
| Regulation Number: | 21 CFR 872.3820 | 21 CFR 872.3820 |
| Product Code: | KIF | KIF |
| Device Class: | II | II |
5.4 Device Description
The subject device is packaged with the following:
- 0 Syringe
- Disposable Tip .
- Silicon Cap .
5.5 Intended Use/Indications for Use
DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material. Application : Root canal filling material / Apexification and hard tissue formation/ Apexogensis
4
Product Name : DIAPEX PLUS
5.6 Technological Characteristics
This device compares to the legally marketed devices as follows:
| | Proposed Device | Primary predicate
device | Reference
predicate device | Discussion |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DiaPex Plus | Vitapex | Metapex | |
| 510(k)
Number | | K973667 | K032603 | - |
| Intended
Use/Indic
ations for
Use | DIAPEX PLUS is a
calcium hydroxide
paste with iodoform,
used as a temporary
root canal filling
material
Application : Root
canal filling material /
Apexification and
hard
tissue
formation/
Apexogensis | VitaPex can be used
as a temporary or
permanent root canal
filling material. It is
ideal for the treatment
of infected root canals
and for vital
pulpotomies In
deciduous teeth. | •Exposed pulp in
capping and
pulpectomy
•Leakage canal
•Apexification
•Formation of hard
tissue barrier
•Root canal filling
material | equivalent |
| Direction
s for Use | •Before using Diapex
Plus, ensure that
the syringe and tip
are free of
damage(e.g. chips,
cracks, deformation,
and/or other
defects)
•Wipe and disinfect
the outer syringe
and tip with alcohol
as tips come
unsterilized.
•After root canal
preparation, the
canal is irrigated
and dried.
•Insert the tip of the
Diapex Plus syringe
to one fifth of foot
canal length from
the apex. the tip is
bent to obtain
easier access to
canal.
•Slowly and gently
press the piston of
the syringe to
extrude the paste.
the paste should
reach the periapical
tissue and the tip
should be pulled out | Extrude VitaPex into
the canal.
place temporary
restoration.
At subsequent visits
remove VitaPex with
sodium hydrochloride
and mechanical
means. | •Clean and dry it
after preparing the
root canal
•Set up a disposable
tip in syringe and
insert the ring
provided for and
easy re-direction of
the tip
•Disinfect the
disposable tip with
ethanol
•Fill the canal
completely by
pushing the syringe
plunger while
withdrawing the tip
slowly
•Clean any excess
paste with a
sterilized cotton
pellet
•Remove the used
tip, fix a new one and
cover up | equivalent |
| | Proposed Device | Primary predicate
device | Reference
predicate device | Discussion |
| | DiaPex Plus | Vitapex | Metapex | |
| | slowly. the paste
should reverse back
to the pulp
chamber.
•After placing the
paste in the canal
and fully removing
the syringe, clean
off any excess
paste.
•After each
application, the
used tip should be
discarded and a
new tip or the
silicon cap put back
on | | | |
| Package
Contents | •Syringe
•Disposable Tip
•Silicon Cap | •Syringe
•Disposable Tip | •Syringe
•Disposable Tip
•One ring rotator for
the direction control
of the tip | |
| Period of
Use | Temporary (remains
in the body for 29
days or less) | Temporary | Temporary | |
| Composit
ion | Calcium Hydroxide
IODOFORM
Polydimethylsiloxane
Olive Oil | Calcium Hydroxide
IODOFORM
Silicone Oil
Inert | Calcium Hydroxide
IODOFORM
Polydimethylsiloxane
Silicone Oil | The main
ingredients are
similar and
have some
other
ingredients.
However,
biocompatibilit
y and
performance
tests confirm
that DiaPex
Plus and
similar
products are
substantially
equivalent. |
| Biocomp
atibility | Biocompatible | Biocompatible | Biocompatible | equivalent |
| Delivery
forms | Premixed paste | Premixed paste | Premixed paste | equivalent |
| Standard
S | ISO 6876 | ISO 6876 | ISO 6876 | equivalent |
5
510k DRAFT SUBMISSION
Diadent Group International
Product Name : DIAPEX PLUS
As demonstrated in the above comparison table, the subject and predicate devices have simil ar intended uses, contraindications, composition and contents, Base and Catalyst part mixture
6
Product Name : DIAPEX PLUS
design, shelf life, biocompatibility, and conformance with standards.
5.7 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:
| Standard | contents | Relevant test | Relevant File |
|---|---|---|---|
| ISO 6876:2012 | Dentistry -- Root canal | ||
| sealing materials | •Flowability | ||
| •Film Thickness | |||
| •Radio-opacity | 18.0 Performance | ||
| Testing- Bench | |||
| ISO 7405:2008 | Dentistry -- Evaluation of biocompatibility of medical | ||
| devices used in dentistry | 15.0 | ||
| Biocompatibility | |||
| ISO 10993-1:2009 | Biological evaluation of medical devices -- Part 1: | ||
| Evaluation and testing within a risk management process | 15.0 | ||
| Biocompatibility | |||
| ISO 10993-3:2014 | Biological evaluation of | ||
| medical devices -- Part 3: | |||
| Tests for genotoxicity, | |||
| carcinogenicity and | |||
| reproductive toxicity | •Genotoxicity Bacterial | ||
| Reverse Mutation | |||
| •Genotoxicity Mouse | |||
| Lymphoma Assay | 15.0 | ||
| Biocompatibility | |||
| ISO 10993-5:2009 | Biological evaluation of | ||
| medical devices -- Part 5: | |||
| Tests for in vitro cytotoxicity | •Cytotoxicity | 15.0 | |
| Biocompatibility | |||
| ISO 10993-6: 2016 | Biological evaluation of | ||
| medical devices -- Part 6: | |||
| Tests for local effects after | |||
| implantation | •4 Week Systemic Toxicity | 15.0 | |
| Biocompatibility | |||
| ISO 10993-10:2010 | Biological evaluation of | ||
| medical devices -- Part 10: | |||
| Tests for irritation and skin | |||
| sensitization | •Sensitization | 15.0 | |
| Biocompatibility | |||
| ISO 10993-11:2017 | Biological evaluation of | ||
| medical devices -- Part 11: | |||
| Tests for systemic toxicity | •Acute Systemic Toxicity | ||
| •Pyrogenicity | |||
| •4 Week Systemic Toxicity | 15.0 | ||
| Biocompatibility |
Additional non-clinical bench testing demonstrates the substantial equivalence of the subject device.
5.8 Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.
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.