(252 days)
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
The subject device is packaged with the following:
- 0 Syringe
- Disposable Tip .
- Silicon Cap .
The provided text is a 510(k) summary for a dental device called "DIAPEX PLUS," a root canal filling material. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence for regulatory clearance. Since this document is a regulatory submission for a medical device that needs to demonstrate substantial equivalence to a predicate device, it contains extensive information about the characteristics of the new device and the predicate device, and how they are similar. This is not a study that presents a test set, acceptance criteria and results against it.
However, based on the information provided, here's an attempt to structure a response using the requested categories, noting where information is not present in the document.
Acceptance Criteria and Study for DIAPEX PLUS
The document provided does not present a typical "acceptance criteria" table with reported performance against specific quantitative thresholds for the device itself. Instead, it demonstrates conformance to recognized international standards and compares the device's technological characteristics to legally marketed predicate devices. The "study" implicitly refers to the non-clinical performance data and the comparison presented to support substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of explicit acceptance criteria with numerical thresholds, the document states conformance to various ISO standards. The "reported device performance" is essentially that the device conforms to these standards and is substantially equivalent to the predicate devices.
| Acceptance Criteria (based on Conformance to Standards and Equivalence) | Reported Device Performance |
|---|---|
| ISO 6876:2012 (Dentistry — Root canal sealing materials) | Conforms |
| - Flowability | Conforms |
| - Film Thickness | Conforms |
| - Radio-opacity | Conforms |
| ISO 7405:2008 (Dentistry — Evaluation of biocompatibility of medical devices used in dentistry) | Conforms |
| ISO 10993-1:2009 (Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process) | Conforms |
| ISO 10993-3:2014 (Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity) | Conforms |
| - Genotoxicity Bacterial Reverse Mutation | Conforms |
| - Genotoxicity Mouse Lymphoma Assay | Conforms |
| ISO 10993-5:2009 (Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity) | Conforms |
| - Cytotoxicity | Conforms |
| ISO 10993-6: 2016 (Biological evaluation of medical devices — Part 6: Tests for local effects after implantation) | Conforms |
| - 4 Week Systemic Toxicity | Conforms |
| ISO 10993-10:2010 (Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization) | Conforms |
| - Sensitization | Conforms |
| ISO 10993-11:2017 (Biological evaluation of medical devices — Part 11: Tests for systemic toxicity) | Conforms |
| - Acute Systemic Toxicity | Conforms |
| - Pyrogenicity | Conforms |
| - 4 Week Systemic Toxicity | Conforms |
| Technological Characteristics (vs. Predicate Devices) | |
| - Intended Use/Indications for Use | Equivalent |
| - Directions for Use | Equivalent |
| - Package Contents (differences noted, but overall equivalence claimed) | Equivalent |
| - Period of Use | Equivalent |
| - Composition | Similar (biocompatibility and performance tests confirm substantial equivalence) |
| - Biocompatibility | Equivalent |
| - Delivery forms | Equivalent |
| - Standards | Equivalent |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated in the document. The non-clinical performance data likely involved various samples tested according to the referenced ISO standards.
- Data provenance: Not explicitly stated. These would typically be laboratory tests conducted by the manufacturer or a contract research organization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided because this is a regulatory submission demonstrating substantial equivalence through conformance to standards and comparison of technical characteristics, not a clinical study with expert-established ground truth. The "ground truth" here is adherence to specified standard test methods and established benchmarks within those standards.
4. Adjudication method for the test set:
- Not applicable as this is not a study requiring adjudication of expert interpretations (e.g., medical imaging classification). The results would be objectively measured parameters defined by the ISO standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a root canal filling material, not an AI-assisted diagnostic tool. No MRMC study was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or AI device. The device's performance is standalone in the sense that its physical and chemical properties and biocompatibility are tested independently.
7. The type of ground truth used:
- The "ground truth" for this submission is established through conformance to international standards (e.g., ISO 6876, ISO 10993 series) and through demonstration of substantial equivalence of technological characteristics to legally marketed predicate devices. The tests are bench tests measuring physical, chemical, and biological properties according to standardized methods.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI device, there is no training set or associated ground truth.
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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
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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 (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)
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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 International16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person: | Myung Sub KimQuality Assurance ManagerPhone: +82-43-266-2315FAX: +82-43-235-2315Email: 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 ProductsCo, 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 predicatedevice | Referencepredicate device | Discussion | |
|---|---|---|---|---|
| DiaPex Plus | Vitapex | Metapex | ||
| 510(k)Number | K973667 | K032603 | - | |
| IntendedUse/Indications forUse | DIAPEX PLUS is acalcium hydroxidepaste with iodoform,used as a temporaryroot canal fillingmaterialApplication : Rootcanal filling material /Apexification andhardtissueformation/Apexogensis | VitaPex can be usedas a temporary orpermanent root canalfilling material. It isideal for the treatmentof infected root canalsand for vitalpulpotomies Indeciduous teeth. | •Exposed pulp incapping andpulpectomy•Leakage canal•Apexification•Formation of hardtissue barrier•Root canal fillingmaterial | equivalent |
| Directions for Use | •Before using DiapexPlus, ensure thatthe syringe and tipare free ofdamage(e.g. chips,cracks, deformation,and/or otherdefects)•Wipe and disinfectthe outer syringeand tip with alcoholas tips comeunsterilized.•After root canalpreparation, thecanal is irrigatedand dried.•Insert the tip of theDiapex Plus syringeto one fifth of footcanal length fromthe apex. the tip isbent to obtaineasier access tocanal.•Slowly and gentlypress the piston ofthe syringe toextrude the paste.the paste shouldreach the periapicaltissue and the tipshould be pulled out | Extrude VitaPex intothe canal.place temporaryrestoration.At subsequent visitsremove VitaPex withsodium hydrochlorideand mechanicalmeans. | •Clean and dry itafter preparing theroot canal•Set up a disposabletip in syringe andinsert the ringprovided for andeasy re-direction ofthe tip•Disinfect thedisposable tip withethanol•Fill the canalcompletely bypushing the syringeplunger whilewithdrawing the tipslowly•Clean any excesspaste with asterilized cottonpellet•Remove the usedtip, fix a new one andcover up | equivalent |
| Proposed Device | Primary predicatedevice | Referencepredicate device | Discussion | |
| DiaPex Plus | Vitapex | Metapex | ||
| slowly. the pasteshould reverse backto the pulpchamber.•After placing thepaste in the canaland fully removingthe syringe, cleanoff any excesspaste.•After eachapplication, theused tip should bediscarded and anew tip or thesilicon cap put backon | ||||
| PackageContents | •Syringe•Disposable Tip•Silicon Cap | •Syringe•Disposable Tip | •Syringe•Disposable Tip•One ring rotator forthe direction controlof the tip | |
| Period ofUse | Temporary (remainsin the body for 29days or less) | Temporary | Temporary | |
| Composition | Calcium HydroxideIODOFORMPolydimethylsiloxaneOlive Oil | Calcium HydroxideIODOFORMSilicone OilInert | Calcium HydroxideIODOFORMPolydimethylsiloxaneSilicone Oil | The mainingredients aresimilar andhave someotheringredients.However,biocompatibility andperformancetests confirmthat DiaPexPlus andsimilarproducts aresubstantiallyequivalent. |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | equivalent |
| Deliveryforms | Premixed paste | Premixed paste | Premixed paste | equivalent |
| StandardS | 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 canalsealing materials | •Flowability•Film Thickness•Radio-opacity | 18.0 PerformanceTesting- Bench |
| ISO 7405:2008 | Dentistry -- Evaluation of biocompatibility of medicaldevices used in dentistry | 15.0Biocompatibility | |
| ISO 10993-1:2009 | Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk management process | 15.0Biocompatibility | |
| ISO 10993-3:2014 | Biological evaluation ofmedical devices -- Part 3:Tests for genotoxicity,carcinogenicity andreproductive toxicity | •Genotoxicity BacterialReverse Mutation•Genotoxicity MouseLymphoma Assay | 15.0Biocompatibility |
| ISO 10993-5:2009 | Biological evaluation ofmedical devices -- Part 5:Tests for in vitro cytotoxicity | •Cytotoxicity | 15.0Biocompatibility |
| ISO 10993-6: 2016 | Biological evaluation ofmedical devices -- Part 6:Tests for local effects afterimplantation | •4 Week Systemic Toxicity | 15.0Biocompatibility |
| ISO 10993-10:2010 | Biological evaluation ofmedical devices -- Part 10:Tests for irritation and skinsensitization | •Sensitization | 15.0Biocompatibility |
| ISO 10993-11:2017 | Biological evaluation ofmedical devices -- Part 11:Tests for systemic toxicity | •Acute Systemic Toxicity•Pyrogenicity•4 Week Systemic Toxicity | 15.0Biocompatibility |
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.
§ 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.