(188 days)
Not Found
No
The summary describes a temporary filling material and does not mention any AI or ML components or functionalities.
No
The device is described as a temporary filling material for dental use, specifically for temporary restorations in a cavity. It does not appear to treat or prevent disease, but rather provide a temporary physical restoration.
No
DiaTemp is described as a temporary filling material for dental restorations, not a device used to diagnose a medical condition or disease. Its intended use is for "temporary fillings, temporary protection in inlay and onlay technique."
No
The device description clearly states it is a "temporary filling material" packaged with a "syringe and protective cap," indicating it is a physical material and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary fillings, temporary protection in inlay and onlay technique." This describes a material used in the mouth for dental procedures, not for testing samples outside the body to diagnose or monitor a medical condition.
- Device Description: The description details a "temporary filling material that sets with curing light" and is packaged in a syringe. This aligns with a dental restorative material, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and restorative within the oral cavity.
N/A
Intended Use / Indications for Use
All types of temporary fillings, temporary protection in inlay and onlay technique.
Product codes
EBG
Device Description
DiaTemp is a temporary filling material that sets with curing light. In case the cavity is not permanently restored, Diatemp can be used as a temporary restoration until the next appointment. DiaTemp has four models and packaged with syringe and protective cap.
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
No clinical data was collected or provided to support substantial equivalence between the subject and predicate device.
Non-clinical performance requirements were evaluated through testing in accordance with harmonized standards: ISO 4049:2009, ISO 7405:2009, ISO 10993-1:2009, ISO 10993-2:2006, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2016, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2012.
Key results from physical characteristics testing include:
- Sensitivity to ambient light: homogeneous for both subject and predicate devices.
- Depth of cure: More than 1.5mm (average: 2.9 mm) for the subject device, 2.5 mm for the predicate device.
- Curing Time: 20 ~ 30 seconds for the subject device, 20 seconds for the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
February 13, 2020
Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si, 28161 Kr
Re: K192158
Trade/Device Name: DiaTemp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: October 1, 2020 Received: October 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 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
1
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known) K192158
Device Name DiaTemp
Indications for Use (Describe)
All types of temporary fillings, temporary protection in inlay and onlay technique.
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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3
5.0 510(k) Summary
5.1 Application Information
| Date Prepared | February 11, 2020 |
|---|---|
| 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 |
5.2 Device Information
| Device Type | Material, Tooth Shade, Resin |
|---|---|
| Regulation Description | Tooth shade resin material. |
| Review Panel | Dental |
| Regulation Number | 21 CFR 872.3690 |
| Product Code | EBF |
| Device Class | II |
| Device Name | DiaTemp |
5.3 Predicate Devices
The legally marketed device to which substantial equivalence is being claimed is:
| 510(k) Number | K111666 |
|---|---|
| Applicant | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
| Device Name | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN |
| Regulation Number | 21 CFR 872.3770 |
| Product Code | EBG |
| Device Class | II |
5.4 Device Description
DiaTemp is a temporary filling material that sets with curing light. In case the cavity is not permanently restored, Diatemp can be used as a temporary restoration until the next appointment. DiaTemp has four models and packaged with syringe and protective cap.
| Model Name | Color | Weight |
|---|---|---|
| DiaTemp Yellow 3g | Yellow | 3g |
| DiaTemp Blue 3g | Blue | 3g |
| DiaTemp Yellow Intro kit 1g | Yellow | 1g |
| DiaTemp Blue Intro kit 1g | Blue | 1g |
5.5 Indications for Use
All types of temporary fillings, temporary protection in inlay and onlay technique.
5.6 Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate device.
4
Product Name: DiaTemp
5.7 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 4049:2009, Dentistry Polymer-based restorative materials ●
- ISO 7405:2009, Dentistry Evaluation of biocompatibility of medical devices used in dentistry ●
- ISO 10993-1:2009, Evaluation and testing within a risk management process
- ISO 10993-2:2006, Animal welfare requirements
- ISO 10993-3:2014, Tests for genotoxicity, carcinogenicity and reproductive toxicity
- . ISO 10993-5:2009, Tests for in vitro cytotoxicity
- . ISO 10993-6:2016, Tests for local effects after implantation
- ISO 10993-10:2010, Tests for irritation and skin sensitization
- ISO 10993-11:2017, Tests for systemic toxicity
- ISO 10993-12:2012, Sample preparation and reference materials
5.8 Technological Characteristics
The technological comparison of the subject device to the predicate device is as follows.
| Subject Device | Primary Predicate Device | Discuss | |
|---|---|---|---|
| 510(k) | |||
| Number | K111666 | ||
| Device code | EBF | EBG | |
| Applicant | DiaDent Group | ||
| International | NEO DENTAL CHEMICAL | ||
| PRODUCTS CO., LTD. | |||
| Device Name | DiaTemp | EVADYNE TEMPORARY | |
| CROWN AND BRIDGE | |||
| RESIN | |||
| Indications | |||
| for Use | All types of temporary | ||
| fillings, temporary | |||
| protection in inlay and | |||
| onlay technique. | Evadyne is a light cured | ||
| single-component material | |||
| for the temporary | |||
| restoration of crowns, | |||
| bridges, or similar dental | |||
| prostheses. Evadyne is | |||
| intended for the general | |||
| dental patient | |||
| population. | Equivalent | ||
| The indications for use of | |||
| the subjective device and | |||
| predicate device is the | |||
| temporary filling, sealing, | |||
| restoration. | |||
| Description | DiaTemp is a temporary | ||
| filling | |||
| material that sets with | |||
| curing light. | |||
| In case the cavity is not | |||
| permanently restored, | |||
| DiaTemp | |||
| can be used as a | |||
| temporary | |||
| restoration until the next | |||
| appointment. | Evadyne is a yellowish | ||
| translucent, lower | |||
| viscosity, light-cured | |||
| temporary restoration | |||
| material for direct filling. | |||
| After curing, Evadyne can | |||
| be removed in one piece | |||
| when the permanent | |||
| restoration is to be placed. | Equivalent | ||
| Package | |||
| Contents | -Syringe | ||
| -Protective Cap | -Syringe | ||
| -Disposable tips | Equivalent | ||
| Composition | -Ethyl 4- | ||
| (N,N-dimethylamino) | |||
| benzoate | |||
| -Silica amorphous,fumed | |||
| -Urethane acrylate | |||
| -BHT | |||
| -Camphorquinone | -Ethyl-4-dimethylamino | ||
| benzoate | |||
| -Fluoroaluminosilicate | |||
| glass | |||
| -Polyester urethane | |||
| dimethacrylat- | The main ingredients are | ||
| similar. Also, | |||
| biocompatibility and | |||
| performance tests | |||
| demonstrate that DiaTemp | |||
| and the predicate device |
5
DiaDent Group International
Product Name: DiaTemp
| | | | are substantially
equivalent. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------|
| Performance
Standard
Conformance | ISO4049 | ISO4049 | Equivalent |
| Physical and
Mechanical
Properties | -Sensitivity to ambient light
-Depth of cure
-Curing time
-Water sorption and
solubility
-Shade & Colour stability | -Sensitivity to ambient light
-Depth of cure
-Curing time | Equivalent |
| Period of Use | Prolonged exposure(B)
(exceed 24 hours but not
30 days) | Prolonged exposure(B)
(exceed 24 hours but not
30 days) | Equivalent |
| Bio-
compatibility | Biocompatible | Biocompatible | Equivalent |
| Use | Prescription/Hospital | Prescription/Hospital | Equivalent |
| Standards | ISO7405 | ISO7405 | Equivalent |
There are similarities between the subject device and predicate device.
The indications for use of the subject device and predicate device is the temporary filling, sealing and restoration. Also, the subject device has similar physical properties to the predicate device.
| Physical characteristics | Subject Device | Predicate Device |
|---|---|---|
| Sensitivity to ambient light | homogeneous | homogeneous |
| Depth of cure | More than 1.5mm | |
| (average: 2.9 mm) | 2.5 mm | |
| Curing Time | 20 ~ 30 seconds | 20 seconds |
However, the composition of the subject device is slightly different from the predicate device. However, the main ingredients are similar. Also, the biocompatibility and performance tests were confirmed.
5.9 Conclusions
Based on the above information and all data provided in this submission, the subject device is substantially equivalent to the legally marketed devices identified in this submission.