Diapex Plus

K182625 · DiaDent Group International · KIF · Jun 3, 2019 · Dental

Device Facts

• Record ID: K182625
• Device Name: Diapex Plus
• Applicant: DiaDent Group International
• Product Code: KIF · Dental
• Decision Date: Jun 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Diapex Plus is a premixed calcium hydroxide and iodoform paste used as a temporary root canal filling material. It is supplied in a syringe with disposable tips and a silicon cap. The device is used by dental professionals in a clinical setting. The clinician inserts the syringe tip into the prepared root canal, extrudes the paste by pressing the piston, and removes the tip. The paste serves as a temporary filling to facilitate apexification and hard tissue formation. After the temporary period, the material is removed from the canal. The device benefits patients by providing a temporary barrier and therapeutic agent during endodontic procedures.

Clinical Evidence

No clinical data was collected or provided. Substantial equivalence is supported by non-clinical bench testing, including flowability, film thickness, and radio-opacity per ISO 6876, and comprehensive biocompatibility testing per ISO 10993 series (cytotoxicity, sensitization, systemic toxicity, genotoxicity).

Technological Characteristics

Premixed paste containing calcium hydroxide, iodoform, polydimethylsiloxane, and olive oil. Delivered via syringe with disposable tips. Conforms to ISO 6876 for root canal sealing materials and ISO 10993 for biocompatibility. Non-sterile delivery; requires disinfection before use.

Indications for Use

Indicated for use as a temporary root canal filling material, apexification, and hard tissue formation/apexogenesis in patients requiring endodontic treatment.

Regulatory Classification

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.

Predicate Devices

• Vitapex (K973667)
• Metapex (K032603)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

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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<br>16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-<br>si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person: | Myung Sub Kim<br>Quality Assurance Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

# 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<br>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

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# Product Name : DIAPEX PLUS

# 5.6 Technological Characteristics

This device compares to the legally marketed devices as follows:

| | Proposed Device | Primary predicate<br>device | Reference<br>predicate device | Discussion |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DiaPex Plus | Vitapex | Metapex | |
| 510(k)<br>Number | | K973667 | K032603 | - |
| Intended<br>Use/Indic<br>ations for<br>Use | DIAPEX PLUS is a<br>calcium hydroxide<br>paste with iodoform,<br>used as a temporary<br>root canal filling<br>material<br>Application : Root<br>canal filling material /<br>Apexification and<br>hard<br>tissue<br>formation/<br>Apexogensis | VitaPex can be used<br>as a temporary or<br>permanent root canal<br>filling material. It is<br>ideal for the treatment<br>of infected root canals<br>and for vital<br>pulpotomies In<br>deciduous teeth. | •Exposed pulp in<br>capping and<br>pulpectomy<br>•Leakage canal<br>•Apexification<br>•Formation of hard<br>tissue barrier<br>•Root canal filling<br>material | equivalent |
| Direction<br>s for Use | •Before using Diapex<br>Plus, ensure that<br>the syringe and tip<br>are free of<br>damage(e.g. chips,<br>cracks, deformation,<br>and/or other<br>defects)<br>•Wipe and disinfect<br>the outer syringe<br>and tip with alcohol<br>as tips come<br>unsterilized.<br>•After root canal<br>preparation, the<br>canal is irrigated<br>and dried.<br>•Insert the tip of the<br>Diapex Plus syringe<br>to one fifth of foot<br>canal length from<br>the apex. the tip is<br>bent to obtain<br>easier access to<br>canal.<br>•Slowly and gently<br>press the piston of<br>the syringe to<br>extrude the paste.<br>the paste should<br>reach the periapical<br>tissue and the tip<br>should be pulled out | Extrude VitaPex into<br>the canal.<br>place temporary<br>restoration.<br>At subsequent visits<br>remove VitaPex with<br>sodium hydrochloride<br>and mechanical<br>means. | •Clean and dry it<br>after preparing the<br>root canal<br>•Set up a disposable<br>tip in syringe and<br>insert the ring<br>provided for and<br>easy re-direction of<br>the tip<br>•Disinfect the<br>disposable tip with<br>ethanol<br>•Fill the canal<br>completely by<br>pushing the syringe<br>plunger while<br>withdrawing the tip<br>slowly<br>•Clean any excess<br>paste with a<br>sterilized cotton<br>pellet<br>•Remove the used<br>tip, fix a new one and<br>cover up | equivalent |
| | Proposed Device | Primary predicate<br>device | Reference<br>predicate device | Discussion |
| | DiaPex Plus | Vitapex | Metapex | |
| | slowly. the paste<br>should reverse back<br>to the pulp<br>chamber.<br>•After placing the<br>paste in the canal<br>and fully removing<br>the syringe, clean<br>off any excess<br>paste.<br>•After each<br>application, the<br>used tip should be<br>discarded and a<br>new tip or the<br>silicon cap put back<br>on | | | |
| Package<br>Contents | •Syringe<br>•Disposable Tip<br>•Silicon Cap | •Syringe<br>•Disposable Tip | •Syringe<br>•Disposable Tip<br>•One ring rotator for<br>the direction control<br>of the tip | |
| Period of<br>Use | Temporary (remains<br>in the body for 29<br>days or less) | Temporary | Temporary | |
| Composit<br>ion | Calcium Hydroxide<br>IODOFORM<br>Polydimethylsiloxane<br>Olive Oil | Calcium Hydroxide<br>IODOFORM<br>Silicone Oil<br>Inert | Calcium Hydroxide<br>IODOFORM<br>Polydimethylsiloxane<br>Silicone Oil | The main<br>ingredients are<br>similar and<br>have some<br>other<br>ingredients.<br>However,<br>biocompatibilit<br>y and<br>performance<br>tests confirm<br>that DiaPex<br>Plus and<br>similar<br>products are<br>substantially<br>equivalent. |
| Biocomp<br>atibility | Biocompatible | Biocompatible | Biocompatible | equivalent |
| Delivery<br>forms | Premixed paste | Premixed paste | Premixed paste | equivalent |
| Standard<br>S | ISO 6876 | ISO 6876 | ISO 6876 | equivalent |

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## 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

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#### 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<br>sealing materials | •Flowability<br>•Film Thickness<br>•Radio-opacity | 18.0 Performance<br>Testing- Bench |
| ISO 7405:2008 | Dentistry -- Evaluation of biocompatibility of medical<br>devices used in dentistry | | 15.0<br>Biocompatibility |
| ISO 10993-1:2009 | Biological evaluation of medical devices -- Part 1:<br>Evaluation and testing within a risk management process | | 15.0<br>Biocompatibility |
| ISO 10993-3:2014 | Biological evaluation of<br>medical devices -- Part 3:<br>Tests for genotoxicity,<br>carcinogenicity and<br>reproductive toxicity | •Genotoxicity Bacterial<br>Reverse Mutation<br>•Genotoxicity Mouse<br>Lymphoma Assay | 15.0<br>Biocompatibility |
| ISO 10993-5:2009 | Biological evaluation of<br>medical devices -- Part 5:<br>Tests for in vitro cytotoxicity | •Cytotoxicity | 15.0<br>Biocompatibility |
| ISO 10993-6: 2016 | Biological evaluation of<br>medical devices -- Part 6:<br>Tests for local effects after<br>implantation | •4 Week Systemic Toxicity | 15.0<br>Biocompatibility |
| ISO 10993-10:2010 | Biological evaluation of<br>medical devices -- Part 10:<br>Tests for irritation and skin<br>sensitization | •Sensitization | 15.0<br>Biocompatibility |
| ISO 10993-11:2017 | Biological evaluation of<br>medical devices -- Part 11:<br>Tests for systemic toxicity | •Acute Systemic Toxicity<br>•Pyrogenicity<br>•4 Week Systemic Toxicity | 15.0<br>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.