(59 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a dental resin cement, with no mention of AI or ML.
No
This device is a dental resin cement used for bonding indirect restorations, not a therapeutic device designed to treat a disease or condition.
No
The device is described as a radiopaque resin cement used for bonding dental restorations. Its intended use and description clearly indicate it is a restorative material, not a device for diagnosing medical conditions.
No
The device description clearly states "Dia-Cem is a radiopaque resin cement," indicating it is a physical material, not software. The performance studies and key metrics also relate to the physical properties of a dental cement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a resin cement for bonding various dental restorations (crowns, bridges, inlays, onlays, posts) to teeth. This is a direct application within the body (or on a part of the body, the tooth).
- Device Description: The description confirms it's a radiopaque resin cement used for bonding.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples taken from the body. This device is used on the body to bond dental materials.
N/A
Intended Use / Indications for Use
- Resin crowns, bridges, inlays and onlays
- Glass Ceramic, Porcelain crowns, inlays and onlays(includes alumina and zirconia)
- Metal crowns, bridges, ing and onlays(includes porcelain-fused-to-metal and composite-to-metal)
- Metal(prefabricated or cast) and fiber posts
Product codes (comma separated list FDA assigned to the subject device)
EMA
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.
Dia-Cem is available in the following models and compositions:
- Dia-Cem TR 9g syringe with various quantities of Automixing tip, Root canal tip, and Eco tip.
- Dia-Cem A2 9g syringe with various quantities of Automixing tip, Root canal tip, and Eco tip.
- Dia-Cem A3O 9g syringe with various quantities of Automixing tip, Root canal tip, and Eco tip.
- Dia-Cem TR 3g + Eco tip 1ea
- Dia-Cem A2 3g + Eco tip 1ea
- Dia-Cem A3O 3g + Eco tip 1ea
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription / Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key results:
- Working time: A homogeneous and thin film should be formed at 60 sec after the complete of mixing.
- Flexural Strength: More than 50 MPa
- Film Thickness: No greater than 50 µm
- Shear bond strength: Equal or greater than 4 MPa
- Biocompatibility: Biocompatible
The test results corresponded to the requirements of standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Working time: A homogeneous and thin film should be formed at 60 sec after the complete of mixing.
- Flexural strength: More than 50 MPa
- Film thickness: No greater than 50 µm
- Shear bond strength: Equal or greater than 4 MPa
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
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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 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
| 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 Group | ||
| International | Bisco, Inc. | - | |
| Device Name | Dia-Cem | BisCem | - |
| 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 | - Luting resin crowns, | ||
| bridges, inlays, onlays | |||
| and veneers |
- Luting porcelain inlays,
onlays, crowns, and
veneers (includes alumina
and zirconia) | Equivalent |
| | (includes porcelain-fused
-to-metal and composite-
to-metal)
-Metal (prefabricated or
cast) and fiber posts | - Luting metal crowns,
bridges, inlay, and onlays
including porcelain-
fused-to-metal and
composite-to-metal
variteties - Luting metal or non-
metal/fiber posts - Luting orthodontic
appliances | |
| Raw Materials | - Ethoxylated bisphenol
A dimethacrylate - 10-Methacryloxy decyl
dihydrogen phosphate - 2-Hydroxyethyl
Methacrylate - Barium glass
- (+/-)-Camphorquinone
- 2, 6-di-tert-butyl-p-
cresol - Pigments | - Bisphenol A
diglycidylmethacrylate - Bis[2-(Methacryloyloxy)
ethyl]Phosphate - 2-Hydroxyethyl
Methacrylate - Bis(Glyceryl 1,3
Dimethacrylate)
Phosphate | * See the below
table. |
| Principle of
operation | Dia-Cem is a radiopaque
resin cement that can be
used in self-cure or light-
cure mode. When the
light is irradiated, the
polymerization is
generated from the
photoinitiator. Also, the
polymerization is
generated from the
reaction which takes
place by the peroxide
initiator. | With its dual syringe
system, BisCem can be
self cured by simply
mixing paste A and paste
B or cured by light after
mixing paste A and paste
B. Using a mixing tip, the
cement could be dispensed
to the working area
directly. | Equivalent |
| Performance
Standard
Conformance | Conformed ISO 4049
and ISO 29022 | Conformed ISO 4049 | Equivalent |
| Physical and
Mechanical
properties
• 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. | 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
strength | Equal or greater than
4 MPa | Equal or greater than
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 |
5
6
- Difference table
| Subject Device | Predicate Device | Discussion |
|---|---|---|
| - Ethoxylated bisphenol A | ||
| dimethacrylate |
- 10-Methacryloxy decyl
dihydrogen phosphate - 2-Hydroxyethyl
Methacrylate - Barium glass
- (+/-)-Camphorquinone
- 2, 6-di-tert-butyl-p-cresol
- Pigments | - Bisphenol A
diglycidylmethacrylate - Bis[2-(Methacryloyloxy)
ethyl]Phosphate - 2-Hydroxyethyl Methacrylate
- Bis(Glyceryl 1,3
Dimethacrylate) Phosphate - Amorphous Silica
- Aluminum oxide | The main raw material,
Ethoxylated bisphenol A
dimethacrylate of the subject
device is similar to Bisphenol
A diglycidylmethacrylate of
the predicate device.
Also, 2-hydroxyethyl
methacrylate is contained in
both subject device and
predicate device
Through the biocompatibility
test results, the difference does
not raise any issue of safety
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.