(266 days)
As a dentine/enamel total etching bonding system for direct adhesion, it is used in the adhesion of all direct restoration substances.
- Bonding of direct composite
- Bonding to composite and set amalgam
- Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays, Veneers, Crowns)
DiaPlus is a photopolymerization type dentine and enamel adhesive as a 5th generation dentine adhesion system that can be applied to all types of composite resin restorations.
The provided text details a 510(k) premarket notification for a dental bonding agent named DiaPlus, aiming to demonstrate its substantial equivalence to a legally marketed predicate device (BC Plus).
However, the document does not contain information about an AI/ML-driven device or an AI/ML-based study with acceptance criteria and associated performance. The 510(k) submission relates to a physical dental bonding agent and its chemical composition, physical properties, and biocompatibility testing. The "study" referenced in the prompt (acceptance criteria, sample sizes, expert ground truth, MRMC, etc.) is consistent with a performance study for an AI/ML medical device, which is not what this document describes.
Therefore, it's not possible to extract the requested information from the provided text. The document focuses on bench testing and biocompatibility for a dental material, not an AI/ML algorithm.
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May 26, 2020
Diadent Group International Kab Sun Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, 28161 KOREA
Re: K192392
Trade/Device Name: DiaPlus Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: February 21, 2020 Received: February 27, 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
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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,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192392
Device Name DIAPLUS
Indications for Use (Describe)
As a dentine/enamel total etching bonding system for direct adhesion, it is used in the adhesion of all direct restoration substances.
-
Bonding of direct composite
-
Bonding to composite and set amalgam
-
Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays, Veneers, Crowns)
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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K192392
DIADENT GROUP INTERNATIONAL
510(k) Summary
1 Application Information
Date Prepared: May 25 2020
Manufacturer:
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: | Agent, Tooth Bonding, Resin |
|---|---|
| Regulation Description: | Resin tooth bonding agent. |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3200 |
| Product Code: | KLE |
| 510(k) Number | K192392 |
| Device Class: | II |
| Device Name: | DIAPLUS |
3 Predicate Devices
| 510(k) Number: | K043562 (Primary Predicate |
|---|---|
| Applicant: | VERICOM Co., Ltd. |
| Device Name: | BC Plus |
| Regulation Number: | 872.3200 |
| Product Code: | KLE |
| Device Class: | Class II |
4 Products configuration
DiaPlus : 1 bottle (5ml)
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K192392
DIADENT GROUP INTERNATIONAL
5 Device Description
DiaPlus is a photopolymerization type dentine and enamel adhesive as a 5th generation dentine adhesion system that can be applied to all types of composite resin restorations.
6 Indications for Use
As a dentine/enamel total etching bonding system for direct adhesion, It is used in the adhesion of all direct restoration substances.
- Bonding of direct composite
- Bonding to composite and set amalgam
- Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays, Veneers, Crowns)
7 Substantial Equivalence discussion
| Subject Device | Primary predicate Device | Discuss | |
|---|---|---|---|
| Product name | DiaPlus | BC Plus | |
| Manufacturer | DiaDent Group International | VERICOM Co., Ltd. | |
| 510K Number | K192392 | K043562 | |
| Product Code | KLE | KLE | |
| DeviceDescription | DiaPlus is a photopolymerization typedentine and enamel adhesive as a 5thgeneration dentine adhesion system that canbe applied to all types of composite resinrestorations. | BC Plus is a single component bondingagent designed to bond composite to dentin,enamel, cast metals, treated porcelain andset amalgam. BC Plus is an ethanol basedformulation of light-activated, adhesiveresin. | |
| Indications forUse | As a dentine/enamel total etching bondingsystem for direct adhesion, it is used in theadhesion of all direct restoration substances.- Bonding of direct composite- Bonding to composite and set amalgam- Bonding of indirect restoration-Porcelain,Composite (Inlays, Onlays, Veneers,Crowns) | BC Plus is a light curing single componentbonding agent use in restorative adhesivedentistry specifically developed for bondingresin-based filling materials (e.g. composite,compomers) to hard dental tissues. Otherindications include bonding of amalgam andlaboratory-produced restorations. BC Pluspermits priming and bonding to be carriedout in single step | |
| ChemicalComposition | - Ethanol- UDMA (Urethane Dimethacrylate)- BisGMA (bisphenolA-glycidyl methacrylate)-TEGDMA (Triethylene glycoldimethacrylate)- HEMA succinate- Champhor quinone | - Ethanol- BisGMA (bisphenolA-glycidylmethacrylate)- HEMA ((Hydroxyethyl)methacrylate)- Champhor quinone |
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K192392
DIADENT GROUP INTERNATIONAL
| Principle ofoperation | Light cured | Light cured | equivalent |
|---|---|---|---|
| Physical andMechanicalproperties | Conformed in accordance with ISO 4049-Bonding strength-Depth of cure-Sensitivity to ambient light | Conformed in accordance with ISO 4049Bonding strengthDepth of cure | equivalent |
| BondingAgent Type | 5th generation bonding agent(Primer & Adhesive combined in one bottle) | 5th generation bonding agent(Primer & Adhesive combined in one bottle) | equivalent |
| Biocompatibility | YesISO 10993-1 :2009 | YesISO 10993-1 :2009 | equivalent |
| RX Only/OTC | RX Only | RX Only | equivalent |
Indication for use -
| Subject device (DiaPlus) | Primary Predicate Device (BCPlus) | |
|---|---|---|
| Description | DiaPlus is a photopolymerization type dentine andenamel adhesive as a 5th generation dentineadhesion system that can be applied to all types ofcomposite resin restorations. | BC Plus is a single component bonding agentdesigned to bond composite to dentin, enamel, castmetals, treated porcelain and set amalgam. BC Plusis an ethanol based formulation of light-activated,adhesive resin. |
| Indication For Use | As a dentine/enamel total etching bonding system fordirect adhesion, it is used in the adhesion of all directrestoration substances.- Bonding of direct composite- Bonding to composite and set amalgam- Bonding of indirect restoration-Porcelain,Composite (Inlays, Onlays, Veneers, Crowns) | BC Plus is a light curing single component bondingagent use in restorative adhesive dentistryspecifically developed for bonding resin-based fillingmaterials (e.g. composite, compomers) to harddental tissues. Other indications include bonding ofamalgam and laboratory-produced restorations. BCPlus permits priming and bonding to be carried out insingle step. |
Discussion:
DiaPlus and BCPlus are photopolymerization type dentine and enamel adhesive using light curing.
The indication for Use of both devices are direct composite and indirect restoration!t seems that the indication of use are similar.
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. Raw material
| Subject device (DiaPlus) | Primary Predicate Device (BCPlus) |
|---|---|
| - Ethyl alcohol | - Ethyl alcohol |
| - UDMA (Urethane Dimethacrylate) | |
| - BisGMA (bisphenolA-glycidyl methacrylate) | - BisGMA (bisphenolA-glycidyl methacrylate) |
| -TEGDMA (Triethylene glycoldimethacrylate) | -HEMA((Hydroxyethyl)methacrylate) |
| - HEMA succinate | - Champhor quinone |
| - Champhor quinone |
Discussion :
The predicate device is composed of Solvent, resin, primer, Photoinitiator for light curing as does the subject device. Results of bench and biocompatibility testing completed in alignment with ISO 4049 and ISO 10993-1, respectively demonstrate that any material differences between the subject device and predicate device do not raise any new questions as to safety and effectiveness. Therefore, it is concluded that DiaPlus is substantially equivalent to the predicate device.
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 4049 Dentistry -- Polymer-based restorative materials
- Dentistry Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry -ISO 7405 [Including: Amendment 1 (2013)]
- -ISO 29022 Dentistry - Adhesive - Notched-edge sheer bond strength test
- -ISO/TS 11405 Dentistry - Testing of adhesion to tooth structure
- -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 1:Evaluation and testing within a risk management process
- -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 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
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DIADENT GROUP INTERNATIONAL
The following Performance tests were conducted.
- -Film Thickness
- -Depth of cure
- -Sensitivity to ambient light
- -Bond strength (Enamel/Dentin)
- -Bond strength (Metal/Veneer)
- -Dentinal tubule occluding property
- = Biocompatibility test
Biocompatibility test:
| Test | Standard | Test result |
|---|---|---|
| Cytotoxicity Study | •10993-5 – Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity | Pass |
| Sensitization Test | •10993-10 – Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization | Pass |
| Oral MucosaIrritation Test | •10993-10 – Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization | Pass |
| Acute SystemicToxicity | •10993-11 – Biological Evaluation of Medical Devices –Part 11: Tests for Systemic Toxicity | Pass |
9 Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.
10 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.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.