DIAPLUS Universal

K213401 · DiaDent Group International · KLE · Jan 31, 2022 · Dental

Device Facts

• Record ID: K213401
• Device Name: DIAPLUS Universal
• Applicant: DiaDent Group International
• Product Code: KLE · Dental
• Decision Date: Jan 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) All direct restorations 2) All indirect restorations 3) Desensitizing/sealing of tooth 4) Intra-oral repairs

Device Story

DIAPLUS Universal is a 7th generation dentin adhesive system; functions as conditioner, primer, and bonding resin. Applied to tooth surface by clinician; solvent volatilized via drying; photopolymerized. Contains 10-MDP monomer with hydrophobic long carbon chain and hydrophilic phosphate group; enhances surface activity and permeability into dentin and enamel; increases bonding to hydroxyapatite. Used in dental clinics for direct/indirect restorations, desensitizing, and intra-oral repairs. Output is a polymerized adhesive layer facilitating restoration retention. Benefits patient by providing stable, durable dental bonding.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and biocompatibility studies conforming to ISO 4049, ISO 7405, ISO 29022, and ISO 10993 series (genotoxicity, cytotoxicity, irritation, systemic toxicity).

Technological Characteristics

Resin-based dentin adhesive. Composition includes 10-MDP, HEMA, BisGMA/TEGDMA, and photoinitiators. Photopolymerization principle. Conforms to ISO 4049 (restorative materials) and ISO 29022 (shear bond strength). Biocompatibility per ISO 10993. Supplied in 1ml/5ml bottles.

Indications for Use

Indicated for all direct and indirect dental restorations, desensitizing or sealing of tooth structure, and intra-oral repairs.

Regulatory Classification

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.

Predicate Devices

• All-Bond Universal w/BAC (K161051)

Submission Summary (Full Text)

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January 31, 2022

Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 SOUTH KOREA

Re: K213401

Trade/Device Name: DIAPLUS Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 29, 2021 Received: October 18, 2021

Dear Kab 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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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# Indications for Use

510(k) Number (if known) K213401

Device Name DIAPLUS Universal

Indications for Use (Describe)

- 1. All direct restorations
- 2. All indirect restorations
- 3. Desensitizing/sealing of tooth
- 4. Intra-oral repairs

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K213401

# 510(k) Summary

### 1 Application Information

| Date Prepared: | Jan 27, 2022 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Kab Sun, Lee<br>Quality Assurance Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

#### 2 Device Information

| 510(k) Number | K213401 |
|---------------------|-----------------------------|
| Classification Name | Agent, Tooth Bonding, Resin |
| Common Name | Resin tooth bonding agent. |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3200 |
| Product Code: | KLE |
| Device Class: | II |
| Trade Name | DIAPLUS Universal |

### 3 Predicate Devices

The legally marketed devices to which substantial equivalence is being claimed are:

| | Primary Predicate Device |
|--------------------|--------------------------|
| 510(k) Number: | K161051 |
| Applicant: | BISCO, Inc. |
| Device Name: | All-Bond Universal w/BAC |
| Regulation Number: | 21 CFR 872.3200 |
| Product Code: | KLE |
| Device Class: | II |

### 4 Device Configuration

DIAPLUS Universal: 1 bottle (5ml, 1ml)

### 5 Device Description

It is a 7th generation dentin adhesive system that handles all the functions of the conditioner primer bonding resin. The polymerization method is photopolymerization type, and after being applied to the tooth surface, the solvent is volatilized and polymerized in the drying process to perform the function as a dentine adhesive.

# 6 Intended Use/Indications for Use

- 1) All direct restorations
- 2) All indirect restorations
- 3) Desensitizing/sealing of tooth
- 4) Intra-oral repairs

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# 7 Comparison Table and Discussion

This device compares to the legally marketed devices as follows:

| | Subject Device | Primary Predicate Device | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Common name | Resin tooth bonding agent. | Resin tooth bonding agent. | |
| Trade Name | DIAPLUS Universal | ALL-BOND Universal w/BAC | Discussion |
| 510(k)<br>Number | K213401 | K161051 | - |
| Indication for<br>Use | 1. All direct restorations<br>2. All indirect restorations<br>3. Desensitizing/sealing of tooth<br>4. Intra-oral repairs | 1. all direct restorations<br>2. all indirect restorations<br>3. intra-oral repairs (i.e. repair of any<br>fixed dental prosthesis containing<br>zirconia, alumina, metals, glass<br>ceramics, tooth<br>structure, and composites)<br>4. desensitizing/sealing of tooth<br>structure<br>5. protective varnish for glass ionomer<br>fillings<br>6. priming of enamel for orthodontic<br>use | Equivalent |
| Composition | - 10-methacryloyloxydecyl<br>dihydrogenphosphate<br>- 2-Hydroxyethyl methacrylate<br>- Bis[2-(methacryloyloxy)ethyl]<br>phosphate<br>- 3-(Trimethoxysilyl)propyl<br>methacrylate<br>- Trimethylolpropane<br>trimethacrylate<br>- BisGMA/TEGDMA Monomer<br>Blend<br>- Poly(ethylene glycol)<br>dimethacrylate<br>- Diphenyliodonium<br>hexafluorophosphate<br>- Phenyl Bis(2,4,6-<br>Trimethylbenzoyl)phosphineoxide<br>- (+/-)Camphorquinone<br>- Ethyl 4-dimethyl aminobenzoate<br>- tert-butyl hydroquinone<br>- Ethyl alcohol<br>- Silicon dioxide | - 10-Methacryloyloxydecyl dihydrogen<br>phosphate<br>- 2-hydroxyethyl methacrylate<br>- Bisphenol A diglycidylmethacrylate<br>- water<br>- ethanol | |
| Principle of<br>operation | After being applied to the tooth<br>surface, the solvent is volatilized<br>and photopolymerized in the<br>drying process to perform the<br>function as a dentin adhesive. The<br>main material, MDP contains a<br>hydrophobic long carbon chain<br>and a hydrophilic phosphate<br>group, so it has excellent surface<br>activity and can easily permeates<br>dentin & enamel. It increases<br>bonding to hydroxyapatite<br>remaining in dentin. | All-Bond Universal is an<br>ethanol/water-based dental adhesive<br>which bonds to dentin and cut and un-<br>cut enamel. | Equivalent |
| Performance<br>Standard<br>Conformance | Conformed<br>ISO 4049 and ISO 29022 | Conformed<br>ISO 4049 and ISO 29022 | Equivalent |
| | Subject Device | Primary Predicate Device | |
| Common name | Resin tooth bonding agent. | Resin tooth bonding agent. | |
| Trade Name | DIAPLUS Universal | ALL-BOND Universal w/BAC | Discussion |
| Physical<br>properties | - Film thickness<br>- Sensitivity to light<br>- Shear bond strength<br>- Occlusion of dental tubules | - Film thickness<br>- Shear bond strength | Equivalent |
| Biocompatibil<br>ity | Biocompatible | Biocompatible | Equivalent |
| Package<br>Contents | One bottle | One bottle | Equivalent |
| RX only/<br>OTC | RX Only | RX Only | equivalent |

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### Differences

## -Composition

| Subject Device<br>(DIAPLUS Universal) | Predicate Device<br>(ALL-BOND Universal w/BAC) | Discussion |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - 10-methacryloyloxydecyl<br>dihydrogen phosphate<br>- 2-Hydroxyethyl methacrylate<br>- Bis[2-(methacryloyloxy)ethyl]<br>phosphate<br>- 3-(Trimethoxysilyl)propyl<br>methacrylate<br>- Trimethylolpropane<br>trimethacrylate<br>- BisGMA/TEGDMA Monomer<br>Blend<br>- Poly(ethylene glycol)<br>dimethacrylate<br>- Diphenyliodonium<br>hexafluorophosphate<br>- Phenyl Bis(2,4,6-<br>Trimethylbenzoyl)phosphineoxide<br>- (+/-) Camphor quinone<br>- Ethyl 4-dimethyl aminobenzoate<br>- tert-butyl hydroquinone<br>- Ethyl alcohol<br>- Silicon dioxide | - 10-Methacryloyloxydecyl<br>dihydrogen phosphate<br>- 2-hydroxyethyl methacrylate<br>- Bisphenol A<br>diglycidylmethacrylate<br>- water<br>- ethanol | The main ingredients (10-<br>methacryloyloxydecyl dihydrogen<br>phosphate, 2-Hydroxyethyl methacrylate)<br>are similar, with some different ingredients.<br>However, the results of biocompatibility<br>and performance tests confirm that<br>DIAPLUS Universal similar products are<br>equivalent. Performance tests confirm that<br>DIAPLUS Universal similar products are<br>equivalent. |

### 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 |
|--------------|------------------------------------------------------------------------------------------------------------------------|
| -ISO 7405 | Dentistry - Evaluation of Biocompatibility of Medical Devices Used In Dentistry<br>[Including: Amendment 1 (2013)] |
| -ISO 29022 | Dentistry - Adhesive - Notched-edge sheer bond strength test |
| -ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a<br>risk management process |
| -ISO 10993-3 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity<br>carcinogenicity and reproductive toxicity |

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| -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<br>sensitization |
| -ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests for Systemic toxicity |

### The following Performance tests were conducted.

- Film Thickness
- Shear Bonding Strength
- Sensitivity to Ambient Light
- Occlusion of dentinal tubules

#### Biocompatibility test:

| Test | Standard | Test result |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Cytotoxicity Study | • 10993-5 - Biological Evaluation of Medical Devices -<br>Part 5: Tests for In Vitro Cytotoxicity | Not<br>Compatible<br>BSE |
| Bacterial Reverse Mutation Study | • 10993-3 - Biological Evaluation of Medical Devices –<br>Part 3: Tests for genotoxicity, carcinogenicity and<br>reproductive toxicity | Compatible |
| In vitro Mammalian Chromosomal Aberration Test | • 10993-3 - Biological Evaluation of Medical Devices -<br>Part 3: Tests for genotoxicity, carcinogenicity and<br>reproductive toxicity | Compatible |
| Mammalian Erythrocyte Micronucleus | • 10993-3 - Biological Evaluation of Medical Devices -<br>Part 3: Tests for genotoxicity, carcinogenicity and<br>reproductive toxicity | Compatible |
| Skin Sensitization Test | • 10993-10 - Biological Evaluation of Medical Devices -<br>Part 10: Tests for Irritation and Skin Sensitization | Compatible |
| Oral Mucosa Irritation Test | • 10993-10 - Biological Evaluation of Medical Devices -<br>Part 10: Tests for Irritation and Skin Sensitization | Compatible |
| Acute Systemic Toxicity | • 10993-11 - Biological Evaluation of Medical Devices -<br>Part 11: Tests for Systemic Toxicity | Compatible |

(Among the components of this product, 10-MDP is an acidic monomer, and depending on the acidity, it is a substance that causes cytotoxicity according to the principle of action of this product, so cytotoxicity test setting the test item is meaningless.

### 9 Clinical Performance Data

No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.

### 10. Conclusion

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.

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