Dia-Cem

K231552 · DiaDent Group International · EMA · Jul 28, 2023 · Dental

Device Facts

• Record ID: K231552
• Device Name: Dia-Cem
• Applicant: DiaDent Group International
• Product Code: EMA · Dental
• Decision Date: Jul 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

Resin crowns, bridges, inlays and onlays Glass Ceramic, Porcelain crowns, inlays and onlays(includes alumina and zirconia) Metal crowns, bridges, inlays and onlays(includes porcelain-fused-to-metal and composite-to-metal) Metal(prefabricated or cast) and fiber posts

Device Story

Dia-Cem is a radiopaque resin cement used for permanent luting of dental restorations (crowns, bridges, inlays, onlays, posts). It is a dual-cure material, functioning via self-cure (peroxide initiator) or light-cure (photoinitiator) modes. The device is supplied in a dual-syringe system with automixing tips for direct application to the working area by dental professionals in a clinical setting. It contains >60% inorganic filler. The clinician applies the cement to the restoration or tooth surface; the material forms a thin, homogeneous film within 60 seconds. The device provides high bonding strength and allows for easy removal of excess material. It benefits patients by providing a durable, radiopaque, and biocompatible luting agent for various restorative materials.

Clinical Evidence

No clinical data was collected or provided. Substantial equivalence is supported by bench testing, including physical/mechanical property testing (ISO 4049, ISO 29022) and biocompatibility evaluation (ISO 7405, ISO 10993-1, -3, -5, -10, -11).

Technological Characteristics

Radiopaque resin cement; dual-cure (self/light). Composition: Ethoxylated bisphenol A dimethacrylate, 10-Methacryloxy decyl dihydrogen phosphate, 2-Hydroxyethyl Methacrylate, Barium glass, Camphorquinone, 2,6-di-tert-butyl-p-cresol, pigments. Form factor: Dual-syringe with automixing tips. Conforms to ISO 4049 (polymer-based restorative materials) and ISO 29022 (shear bond strength). Non-sterile; 2-year shelf life.

Indications for Use

Indicated for luting resin, glass ceramic, porcelain, and metal (including PFM and composite-to-metal) crowns, bridges, inlays, and onlays, as well as metal (prefabricated or cast) and fiber posts.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• BisCem (K082449)

Submission Summary (Full Text)

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July 28, 2023

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

Re: K231552

Trade/Device Name: Dia-Cem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: May 16, 2023 Received: May 30, 2023

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.

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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 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.

# Michael E. Adjodha -S

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)

K231552

Device Name Dia-Cem

Indications for Use (Describe)

- Resin crowns, bridges, inlays and onlays
- Glass Ceramic, Porcelain crowns, inlays and onlays(includes alumina and zirconia)
- Metal crowns, bridges, inlays and onlays(includes porcelain-fused-to-metal and composite-to-metal)
- Metal(prefabricated or cast) and fiber posts

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

| <div> <b> <span style="font-size:14px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </b> </div> |
|-----------------------------------------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# K231552

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

#### 1. Application Information

| Date Prepared | May 10, 2023 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and Address | DiaDent Group International<br>16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,<br>Cheongju-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

| Common Name | Dental Resin Cement |
|---------------------|----------------------------------|
| Trade Name | Dia-Cem |
| Classification Name | Cement, Dental (21 CFR 872.3275) |
| Product Code | EMA |
| Device Class | II |

## 3. Primary Predicate Device

| 510(k) Number | K082449 |
|-------------------|-----------------|
| Applicant | BISCO, Inc. |
| Device Name | BisCem |
| Regulation Number | 21 CFR 872.3275 |
| Product Code | EMA |
| Device Class | II |

## 4. Device Description

Dia-Cem is a radiopaque resin cement that can be used in self-cure or light-cure mode. It corresponds to type 2 and 3 of ISO 4049 and contains more than 60% of inorganic filler. Dia-Cem shows high bonding strength on various materials, yet excess material can be easily removed. 3 different shades are available: TR, A2, and A3O.

| No. | Model Name | Composition |
|-----|---------------|----------------------------------------------------------------------------------------|
| 1 | Dia-Cem TR 9g | Dia-Cem TR 9g syringe 1ea + Automixing tip 3ea +<br>Root canal tip 3ea + Eco tip 1ea |
| | | Dia-Cem TR 9g syringe 1ea + Automixing tip 5ea +<br>Root canal tip 5ea + Eco tip 1ea |
| | | Dia-Cem TR 9g syringe 1ea + Automixing tip 10ea +<br>Root canal tip 10ea + Eco tip 1ea |
| | | Dia-Cem TR 9g syringe 1ea + Automixing tip 10ea + Eco tip 1ea |
| | | Dia-Cem TR 9g syringe 1ea + Automixing tip 5ea + Eco tip 1ea |

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| | | Dia-Cem TR 9g syringe 1ea + Automixing tip 3ea + Eco tip 1ea |
|---|----------------|-----------------------------------------------------------------------------------------|
| 2 | Dia-Cem A2 9g | Dia-Cem A2 9g syringe 1ea + Automixing tip 3ea +<br>Root canal tip 3ea + Eco tip 1ea |
| | | Dia-Cem A2 9g syringe 1ea + Automixing tip 5ea +<br>Root canal tip 5ea + Eco tip 1ea |
| | | Dia-Cem A2 9g syringe 1ea + Automixing tip 10ea +<br>Root canal tip 10ea + Eco tip 1ea |
| | | Dia-Cem A2 9g syringe 1ea + Automixing tip 10ea + Eco tip 1ea |
| | | Dia-Cem A2 9g syringe 1ea + Automixing tip 5ea + Eco tip 1ea |
| | | Dia-Cem A2 9g syringe 1ea + Automixing tip 3ea + Eco tip 1ea |
| 3 | Dia-Cem A3O 9g | Dia-Cem A3O 9g syringe 1ea + Automixing tip 3ea +<br>Root canal tip 3ea + Eco tip 1ea |
| | | Dia-Cem A3O 9g syringe 1ea + Automixingtip 5ea +<br>Root canal tip 5ea + Eco tip 1ea |
| | | Dia-Cem A3O 9g syringe 1ea + Automixing tip 10ea +<br>Root canal tip 10ea + Eco tip 1ea |
| | | Dia-Cem A3O 9g syringe 1ea + Automixing tip 10ea + Eco tip 1ea |
| | | Dia-Cem A3O 9g syringe 1ea + Automixing tip 5ea + Eco tip 1ea |
| | | Dia-Cem A3O 9g syringe 1ea + Automixing tip 3ea + Eco tip 1ea |
| 4 | Dia-Cem TR 3g | Dia-Cem TR 3g + Eco tip 1ea |
| 5 | Dia-Cem A2 3g | Dia-Cem A2 3g + Eco tip 1ea |
| 6 | Dia-Cem A3O 3g | Dia-Cem A30 3g + Eco tip 1ea |

## 5. Indications for Use

- Resin crowns, bridges, inlays and onlays

- Glass Ceramic, Porcelain crowns, inlays and onlays(includes alumina and zirconia)

- Metal crowns, bridges, inlays and onlays(includes porcelain-fused-to-metal and composite-to-metal)

- Metal(prefabricated or cast) and fiber posts

## 6. Technological Characteristics

The subject device, Dia-Cem has similar characteristics to the primary predicate device, BisCem.

[Comparison table]

| | Subject Device | Predicate Device | Discuss |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| 510(k) Number | - | K082449 | - |
| Product Code | EMA | EMA | Equivalent |
| Device Class | II | II | Equivalent |
| Manufacturer | DiaDent Group<br>International | Bisco, Inc. | - |
| Device Name | Dia-Cem | BisCem | - |
| Indications for Use | -Resin crowns, bridges,<br>inlays and onlays<br>-Glass Ceramic, Porcelain<br>crowns, inlays and<br>onlays (includes alumina<br>and zirconia)<br>-Metal crowns, bridges,<br>inlays and onlays | - Luting resin crowns,<br>bridges, inlays, onlays<br>and veneers<br>- Luting porcelain inlays,<br>onlays, crowns, and<br>veneers (includes alumina<br>and zirconia) | Equivalent |
| | (includes porcelain-fused<br>-to-metal and composite-<br>to-metal)<br>-Metal (prefabricated or<br>cast) and fiber posts | - Luting metal crowns,<br>bridges, inlay, and onlays<br>including porcelain-<br>fused-to-metal and<br>composite-to-metal<br>variteties<br>- Luting metal or non-<br>metal/fiber posts<br>- Luting orthodontic<br>appliances | |
| Raw Materials | - Ethoxylated bisphenol<br>A dimethacrylate<br>- 10-Methacryloxy decyl<br>dihydrogen phosphate<br>- 2-Hydroxyethyl<br>Methacrylate<br>- Barium glass<br>- (+/-)-Camphorquinone<br>- 2, 6-di-tert-butyl-p-<br>cresol<br>- Pigments | - Bisphenol A<br>diglycidylmethacrylate<br>- Bis[2-(Methacryloyloxy)<br>ethyl]Phosphate<br>- 2-Hydroxyethyl<br>Methacrylate<br>- Bis(Glyceryl 1,3<br>Dimethacrylate)<br>Phosphate | * See the below<br>table. |
| Principle of<br>operation | Dia-Cem is a radiopaque<br>resin cement that can be<br>used in self-cure or light-<br>cure mode. When the<br>light is irradiated, the<br>polymerization is<br>generated from the<br>photoinitiator. Also, the<br>polymerization is<br>generated from the<br>reaction which takes<br>place by the peroxide<br>initiator. | With its dual syringe<br>system, BisCem can be<br>self cured by simply<br>mixing paste A and paste<br>B or cured by light after<br>mixing paste A and paste<br>B. Using a mixing tip, the<br>cement could be dispensed<br>to the working area<br>directly. | Equivalent |
| Performance<br>Standard<br>Conformance | Conformed ISO 4049<br>and ISO 29022 | Conformed ISO 4049 | Equivalent |
| Physical and<br>Mechanical<br>properties<br>• Working time | A homogeneous and<br>thin film should be<br>formed at 60 sec after<br>the complete of<br>mixing. | A homogeneous and thin<br>film should be formed at<br>60 sec after the complete<br>of mixing. | Equivalent |
| • Flexural strength | More than 50 MPa | More than 50 MPa | Equivalent |
| • Film thickness | No greater than 50 µm | No greater than 50 µm | Equivalent |
| • Shear bond<br>strength | Equal or greater than<br>4 MPa | Equal or greater than<br>4 MPa | Equivalent |
| Biocompatibility | Biocompatible | Biocompatible | Equivalent |
| Use | Prescription / Hospital | Prescription / Hospital | Equivalent |
| Period of use | Permanent | Permanent | Equivalent |
| Sterility | Non-sterile | Non-sterile | Equivalent |
| Shelf-life | 2 years | 2 years | Equivalent |

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* Difference table

| Subject Device | Predicate Device | Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - Ethoxylated bisphenol A<br>dimethacrylate<br>- 10-Methacryloxy decyl<br>dihydrogen phosphate<br>- 2-Hydroxyethyl<br>Methacrylate<br>- Barium glass<br>- (+/-)-Camphorquinone<br>- 2, 6-di-tert-butyl-p-cresol<br>- Pigments | - Bisphenol A<br>diglycidylmethacrylate<br>- Bis[2-(Methacryloyloxy)<br>ethyl]Phosphate<br>- 2-Hydroxyethyl Methacrylate<br>- Bis(Glyceryl 1,3<br>Dimethacrylate) Phosphate<br>- Amorphous Silica<br>- Aluminum oxide | The main raw material,<br>Ethoxylated bisphenol A<br>dimethacrylate of the subject<br>device is similar to Bisphenol<br>A diglycidylmethacrylate of<br>the predicate device.<br>Also, 2-hydroxyethyl<br>methacrylate is contained in<br>both subject device and<br>predicate device<br>Through the biocompatibility<br>test results, the difference does<br>not raise any issue of safety<br>and effectiveness. |

#### 7. Non-Clinical Performance Data

The performance and biological tests were conducted on the subject device: Dia-Cem according to the following standards.

ISO 4049:2019, Dentistry - Polymer - based restorative materials

ISO 29022:2013, Dentistry - Adhesion - Notched - edge shear bond strength test

ISO 7405:2018, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

ISO 10993-1:2018, Evaluation and testing within a risk management process

ISO 10993-3:2014, Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-5:2009, Tests for in vitro cytotoxicity

ISO 10993-10:2010, Tests for irritation and skin sensitization

ISO 10993-11:2017, Tests for systemic toxicity

The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent in safety and effectiveness to the predicate device.

#### 8. Clinical Performance Data

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

#### 9. Conclusions

Based on the above information and all data provided in this submission, the subject device is substantially equivalent to the legally marketed device identified in this submission.