(59 days)
- 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
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.
This document describes the premarket notification (510(k)) for the Dia-Cem dental cement. It focuses on demonstrating substantial equivalence to a predicate device, BisCem, rather than presenting a study proving a device meets specific acceptance criteria in the manner of an AI/ML device.
Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not directly applicable as this is a material science characterization for a traditional medical device, not an AI/ML algorithm.
Here's the information extracted that aligns with your request:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device - Dia-Cem) |
|---|---|---|
| Working time | A homogeneous and thin film should be formed at 60 sec after the complete of mixing. | A homogeneous and thin film should be formed at 60 sec after the complete of mixing. |
| Flexural strength | More than 50 MPa | More than 50 MPa |
| Film thickness | No greater than 50 µm | No greater than 50 µm |
| Shear bond strength | Equal or greater than 4 MPa | Equal or greater than 4 MPa |
| Biocompatibility | Biocompatible | Biocompatible |
| Shelf-life | 2 years | 2 years |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable in the provided document. The document describes non-clinical performance data based on ISO standards for material properties, not a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable in the provided document. Ground truth, in the context of expert review, is not relevant for this type of material science testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the provided document.
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 in the provided document. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the provided document. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance data: The "ground truth" or reference for the device's performance is established by international standards such as ISO 4049:2019, ISO 29022:2013, ISO 7405:2018, ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017. These standards define the methodologies and acceptable limits for the physical, mechanical, and biocompatibility properties of dental cement.
8. The sample size for the training set
- Not applicable in the provided document. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable in the provided document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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.
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.
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
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) |
|---|
| ------------------------------------------------- |
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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 International16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person | Kab Sun LeeQuality Assurance ManagerPhone: +82-43-266-2315FAX: +82-43-235-2315Email: diadent32@diadent.co.kr |
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 +Root canal tip 3ea + Eco tip 1ea |
| Dia-Cem TR 9g syringe 1ea + Automixing tip 5ea +Root canal tip 5ea + Eco tip 1ea | ||
| Dia-Cem TR 9g syringe 1ea + Automixing tip 10ea +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 |
{4}------------------------------------------------
| 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 +Root canal tip 3ea + Eco tip 1ea |
| Dia-Cem A2 9g syringe 1ea + Automixing tip 5ea +Root canal tip 5ea + Eco tip 1ea | ||
| Dia-Cem A2 9g syringe 1ea + Automixing tip 10ea +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 +Root canal tip 3ea + Eco tip 1ea |
| Dia-Cem A3O 9g syringe 1ea + Automixingtip 5ea +Root canal tip 5ea + Eco tip 1ea | ||
| Dia-Cem A3O 9g syringe 1ea + Automixing tip 10ea +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 GroupInternational | Bisco, Inc. | - |
| Device Name | Dia-Cem | BisCem | - |
| Indications for Use | -Resin crowns, bridges,inlays and onlays-Glass Ceramic, Porcelaincrowns, inlays andonlays (includes aluminaand zirconia)-Metal crowns, bridges,inlays and onlays | - Luting resin crowns,bridges, inlays, onlaysand veneers- Luting porcelain inlays,onlays, crowns, andveneers (includes aluminaand zirconia) | Equivalent |
| (includes porcelain-fused-to-metal and composite-to-metal)-Metal (prefabricated orcast) and fiber posts | - Luting metal crowns,bridges, inlay, and onlaysincluding porcelain-fused-to-metal andcomposite-to-metalvariteties- Luting metal or non-metal/fiber posts- Luting orthodonticappliances | ||
| Raw Materials | - Ethoxylated bisphenolA dimethacrylate- 10-Methacryloxy decyldihydrogen phosphate- 2-HydroxyethylMethacrylate- Barium glass- (+/-)-Camphorquinone- 2, 6-di-tert-butyl-p-cresol- Pigments | - Bisphenol Adiglycidylmethacrylate- Bis[2-(Methacryloyloxy)ethyl]Phosphate- 2-HydroxyethylMethacrylate- Bis(Glyceryl 1,3Dimethacrylate)Phosphate | * See the belowtable. |
| Principle ofoperation | Dia-Cem is a radiopaqueresin cement that can beused in self-cure or light-cure mode. When thelight is irradiated, thepolymerization isgenerated from thephotoinitiator. Also, thepolymerization isgenerated from thereaction which takesplace by the peroxideinitiator. | With its dual syringesystem, BisCem can beself cured by simplymixing paste A and pasteB or cured by light aftermixing paste A and pasteB. Using a mixing tip, thecement could be dispensedto the working areadirectly. | Equivalent |
| PerformanceStandardConformance | Conformed ISO 4049and ISO 29022 | Conformed ISO 4049 | Equivalent |
| Physical andMechanicalproperties• Working time | A homogeneous andthin film should beformed at 60 sec afterthe complete ofmixing. | A homogeneous and thinfilm should be formed at60 sec after the completeof 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 bondstrength | Equal or greater than4 MPa | Equal or greater than4 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 |
{5}------------------------------------------------
{6}------------------------------------------------
- Difference table
| Subject Device | Predicate Device | Discussion |
|---|---|---|
| - Ethoxylated bisphenol Adimethacrylate- 10-Methacryloxy decyldihydrogen phosphate- 2-HydroxyethylMethacrylate- Barium glass- (+/-)-Camphorquinone- 2, 6-di-tert-butyl-p-cresol- Pigments | - Bisphenol Adiglycidylmethacrylate- Bis[2-(Methacryloyloxy)ethyl]Phosphate- 2-Hydroxyethyl Methacrylate- Bis(Glyceryl 1,3Dimethacrylate) Phosphate- Amorphous Silica- Aluminum oxide | The main raw material,Ethoxylated bisphenol Adimethacrylate of the subjectdevice is similar to BisphenolA diglycidylmethacrylate ofthe predicate device.Also, 2-hydroxyethylmethacrylate is contained inboth subject device andpredicate deviceThrough the biocompatibilitytest results, the difference doesnot raise any issue of safetyand 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.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.