DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit

K192273 · DiaDent Group International · KLE · Feb 7, 2020 · Dental

Device Facts

• Record ID: K192273
• Device Name: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
• Applicant: DiaDent Group International
• Product Code: KLE · Dental
• Decision Date: Feb 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

Device Story

DiaEtch is a blue-colored, thixotropic gel containing 37% phosphoric acid. It is supplied in pre-filled syringes with disposable tips. The device is used by dental professionals in a clinical setting to etch enamel and dentin surfaces. The etching process removes the smear layer and creates micro-retentive surface topography, which facilitates the bonding of restorative materials and adhesives to the tooth structure. The clinician applies the gel to the target area, allows it to react, and then rinses it off. This preparation step is essential for ensuring the long-term retention and clinical success of dental restorations.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included pH (1.4 ± 0.2), viscosity (60,000 cps), and density (1.2). Biocompatibility testing conducted per ISO 10993-5 and ISO 10993-10, including cytotoxicity, sensitization, and oral mucosa irritation, all of which passed.

Technological Characteristics

Thixotropic gel; 37% phosphoric acid, water, citric acid anhydrous, silicone dioxide, xanthan gum, ethyl alcohol, colorant. pH 1.4 ± 0.2; viscosity 60,000 cps. Delivered via pre-filled syringe. Biocompatibility per ISO 7405, ISO 10993-1, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials in dental patients.

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

• seity 37% Phosphoric Acid Etching Gel (K112597)
• Acid Etchant (K172953)

Submission Summary (Full Text)

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February 7, 2020

Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, 28161 Kr

Re: K192273

Trade/Device Name: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 1, 2020 Received: August 1, 2020

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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,

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) K192273

Device Name DIAETCH

Indications for Use (Describe)

DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

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 : DIAETCH

# 510(k) Summary

# 1 Application Information

| Date Prepared: | February 6, 2020 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and<br>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

| Device Type: | Agent, Tooth Bonding, Resin |
|-------------------------|-----------------------------|
| Regulation Description: | Resin tooth bonding agent. |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3200 |
| Product Code: | KLE |
| Device Class: | II |
| Device Name: | DIAETCH |

### 3 Predicate Devices

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

| | Primary Predicate Device | Reference Predicate Device |
|-----------------------|------------------------------------------|----------------------------|
| 510(k) Number: | K112597 | K172953 |
| Applicant: | MYCONE DENTAL SUPPLY CO., INC. | American Orthodontics |
| Device Name: | seity 37% Phosphoric Acid Etching<br>Gel | Acid Etchant |
| Regulation<br>Number: | 21 CFR 872.3200 | 21 CFR 872.3200 |
| Product Code: | KLE | KLE |
| Device Class: | II | II |

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### 4 Products configuration

Each models of subject device configuration is described as following:

| Model Name | Product Configuration |
|-------------------------|---------------------------------------------------------------|
| Economic Package Type A | Syringes with 5ml of products x 5ea<br>Disposable tips x 20ea |
| Regular Package | Syringes with 3ml of products x 2ea<br>Disposable tips x 10ea |
| Refill Package Type A | Syringes with 5ml of products x 1ea<br>Disposable tips x 5ea |
| Intro Kit | Syringes with 3ml of products x 1ea<br>Disposable tips x 2ea |

### 5 Device Description

Blue colored gel-type substance containing 37% phosphoric acid that corrodes enamel and dentine.

### 6 Indications for Use

DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials

### 7. Substantial Equivalence

| | Subject Device | Primary Predicate Device | Reference Predicate Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | DiaEtch | Seity 37% Phosphoric Acid<br>Etching Gel | Acid Etchant |
| Manufacturer | DiaDent Group International | Mycone Dental | American Orthodontics |
| 510K Number | - | K112597 | K172953 |
| Product Code | KLE | KLE | KLE |
| Indications<br>For<br>Use | DiaEtch is a 37% phosphoric<br>acid etchant used for etching<br>enamel and dentin to promote<br>adhesion of primer/bonding<br>agent<br>adhesives<br>to tooth<br>structure<br>and<br>restorative<br>materials | A thixotropic 37% phosphoric<br>acid dental etchant gel<br>for<br>etching enamel, dentin,<br>and<br>glass<br>ionomer<br>cements<br>to<br>produce the necessary micro-<br>retentive surface for successful<br>bonding of restorations. | Acid Etchant is a phosphoric acid<br>etchant used for etching enamel<br>and dentin to promote adhesion<br>of<br>primer/bonding<br>agent<br>adhesives to tooth structure and<br>restorative materials. |

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# Diadent Group International

# Product Name : DIAETCH

| Material<br>Composition | -. Phosphoric acid 37%<br>-. Water<br>-. Citric acid anhydrous<br>-. Silicone dioxide<br>-. Xanthan Gum<br>-. Ethyl alcohol<br>-. Colorant | -. Phosphoric acid 37% | -. Phosphoric acid 25~50%<br>-. Water<br>-. Silicon Dioxide<br>-. Surfactants<br>-. Blue colorant |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Device<br>description | Thixotropic dental etchant gel<br>with 37% phosphoric acid | Thixotropic dental etchant gel<br>with 37% phosphoric acid | Thixotropic dental etchant gel<br>with 37% phosphoric acid |
| Physical<br>and<br>Mechanical<br>Properties | -. Ph : $1.4\pm0.2$<br>-. Viscosity : 60,000cps<br>-. Consistency : Thick gel<br>-. Color : Blue or dark blue | -. pH : 1.52<br>-. Viscosity : 60,000cps<br>-. Consistency : Thick gel<br>-. Color : Blue or green | -. pH_<2<br>-. Consistency : Thick gel<br>-. Color : Blue or green |
| Use | Prescription/Hospital | Prescription/Hospital | Prescription/Hospital |
| Delivery forms<br>(Design) | Pre-filled syringe | Pre-filled syringes | Pre-filled syringe |

### - Indications For Use

| Subject Device | Predicate Devices(K112597) | Predicate Devices(K172953) | Discussion |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DiaEtch is a 37%<br>phosphoric acid etchant<br>used for etching enamel<br>and dentin to promote<br>adhesion of<br>primer/bonding agent<br>adhesives to tooth<br>structure and restorative<br>materials | A thixotropic 37%<br>phosphoric acid dental<br>etchant gel for etching<br>enamel, dentin, and glass<br>ionomer cements to produce<br>the necessary micro-<br>retentive surface for<br>successful bonding of<br>restorations. | Acid Etchant is a phosphoric<br>acid etchant used for etching<br>enamel and dentin to<br>promote adhesion of<br>primer/bonding agent<br>adhesives to tooth structure<br>and restorative materials. | The substance of the subject<br>device is identical with the<br>predicate devices (Substance<br>is Thixotropic dental etchant<br>gel with 37% phosphoric acid)<br>and the main function of<br>devices is to help improve<br>adhesion of resin/restorations.<br>Therefore, the Indication for<br>use of the subject and<br>predicate device is not<br>significantly different and the<br>safety and performance is not<br>expected to be affected by<br>these differences. |

### -Composition

| Subject Device | Predicate Device(Primary) | Predicate Device(Reference) | Discussion |
|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -. Phosphoric acid 37%<br>-. Water<br>-. Citric acid anhydrous<br>-. Silicone dioxide<br>-. Xanthan Gum<br>-. Ethyl alcohol<br>-. Colorant | -. Phosphoric acid 37%<br>-. Water<br>-. Additives | -. Phosphoric acid 25~50%<br>-. Water<br>-. Silicon Dioxide<br>-. Surfactants<br>-. Blue colorant | The main ingredient of<br>subject and predicate<br>devices is Phosphoric acid.<br>and the functions of other<br>additives are similar (base,<br>thicker, surfactants,<br>colorant).<br>Also, the biocompatibility of<br>subject device was<br>confirmed by biological<br>safety study. |

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#### Product Name : DIAETCH

#### 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 7405 Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
- -ISO 10993-1 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

The following Performance tests were conducted.

- pH -
- -Viscosity
- Density -
- Biocompatibility test -

#### Performance test (Physical properties):

| Test | DiaEtch | Primary predicate device |
|-----------|---------------|--------------------------|
| pH | $1.4 \pm 0.2$ | 1.52 |
| Viscosity | 60,000 cps | 60,000 cps |
| Density | 1.2 | |

#### Biocompatibility test:

| Test | Standard | Test result |
|------------------------|-------------------------------------------------------------------------------------------------------------------|-------------|
| Cytotoxicity | ISO 10993-5 - Biological evaluation of medical devices -<br>Part 5. Tests for in vitro Cytotoxicity | Pass |
| Sensitization | ISO 10993-10 - Biological Evaluation Of Medical Devices -<br>Part 10: Tests For Irritation And Skin Sensitization | Pass |
| Oral Mucosa Irritation | ISO 10993-10 - Biological Evaluation Of Medical Devices -<br>Part 10: Tests For Irritation And Skin Sensitization | Pass |

#### 9. Conclusion

Based on the above information and all data provided in this submission, including comparison of intended uses, technological characteristics discussion of differences of subject and predicate devices, show that the subject device and the predicate device have similar technical characteristic and chemical composition.

It is demonstrated that the subject device and the legally marketed devices identified in this submission are substantially equivalent.