(199 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical use as a temporary filling material, with no mention of AI/ML or data processing.
Yes
The device is a temporary filling material used for temporary inlay/onlay treatments, sealing implant screw openings, relining temporary crowns/bridges, and covering the gingival margin, all of which are therapeutic interventions.
No
The device description and intended use indicate it is a temporary dental filling material for restorative purposes, not for diagnosing a condition.
No
The device description clearly states it is a "temporary filling material" and is "packaged with the syringe, disposable tip, protective cap," indicating it is a physical material and associated hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to temporary dental restorations and procedures performed directly on a patient's body (in the mouth). IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description clearly states it's a "temporary filling material" used for "temporary restoration until the next appointment." This is a therapeutic/restorative function, not a diagnostic one.
- Anatomical Site: The anatomical sites mentioned (cavity, implant screw openings, crowns/bridges, gingival margin) are all locations within the mouth where a dental procedure is performed.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical characteristics of an IVD.
Therefore, DiaTemp Flow is a dental device used for temporary restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Temporary inlay and onlay treatments of the cavity.
-
- Sealing of openings for implant screws.
-
- Relining material for temporary crowns and bridges.
-
- Covering of the gingival margin.
-
- Fixing of resin matrix during filling placement.
Product codes
EBG
Device Description
DiaTemp Flow is a temporary fililng material that sets with curing light. In case that the cavity is not permanently restored, DiaTemp Flow can be used as a temporary restoration until the next appointment. DiaTemp Flow has four models and packaged with the syringe, disposable tip, 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 Use (Part 21 CFR 801 Subpart D)
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.
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
Key Results: The main ingredients are similar. Also, biocompatibility and performance tests demonstrate that DiaTemp Flow and the predicate device are substantially equivalent.
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 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.
February 13, 2020
Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, 28161 KOREA
Re: K192022
Trade/Device Name: DiaTemp Flow 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
1
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 (OS) 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) K192022
Device Name DiaTemp Flow
Indications for Use (Describe)
-
- Temporary inlay and onlay treatments of the cavity.
-
- Sealing of openings for implant screws.
-
- Relining material for temporary crowns and bridges.
-
- Covering of the gingival margin.
-
- Fixing of resin matrix during filling placement.
| 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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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 | Crown And Bridge, Temporary, Resin |
|---|---|
| Regulation Description | Temporary crown and bridge resin. |
| Review Panel | Dental |
| Regulation Number | 21 CFR 872.3770 |
| Product Code | EBG |
| Device Class | II |
| Device Name | DiaTemp Flow |
5.3 Predicate Devices
The legally marketed device to which substantial equivalence is being claimed is:
| 510(k) Number | K153493 |
|---|---|
| Applicant | VOCO GmbH |
| Device Name | Clip Flow |
| Regulation Number | 21 CFR 872.3690 |
| Product Code | EBF |
| Device Class | II |
5.4 Device Description
DiaTemp Flow is a temporary fililng material that sets with curing light. In case that the cavity is not permanently restored, DiaTemp Flow can be used as a temporary restoration until the next appointment. DiaTemp Flow has four models and packaged with the syringe, disposable tip, protective cap.
| Model Name | Color | Weight |
|---|---|---|
| DiaTemp Flow Yellow 1.8g | Yellow | 1.8g |
| DiaTemp Flow Blue 1.8g | Blue | 1.8g |
| DiaTemp Flow Yellow Intro kit 0.5g | Yellow | 0.5g |
| DiaTemp Flow Blue Intro kit 0.5g | Blue | 0.5g |
5.5 Indication for Use
-
- Temporary inlay and onlay treatments of the cavity.
-
- Sealing of openings for implant screws.
-
- Relining material for temporary crowns and bridges.
-
- Covering of the gingival margin.
-
- Fixing of resin matrix during filling placement.
4
Product Name: DiaTemp Flow
5.6 Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate device.
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 | K153493 | ||
| Product code | EBG | EBF | |
| Applicant | DiaDent | ||
| Group | |||
| International | VOCO GmBH | ||
| Device Name | DiaTemp Flow | Clip Flow | |
| Indications for | |||
| Use | 1. Temporary inlay and | ||
| onlay treatments of the | |||
| cavity. |
- Sealing of openings for
implant screws. - Relining material for
temporary crowns and
bridges. - Covering of the gingival
margin. - Fixing of resin matrix
during filling placement. | 1. Temporary inlay and
onlay treatments of the
cavity. - Sealing of openings for
implant screws. - Relining material for
temporary crowns and
bridges. - Block-out material for
retentive areas in the
dental arch, e.g. before
taking impressions. - Covering of the gingival
margin. - Fixing of resin matrix
during filling placement. | Equivalent |
| Description | DiaTemp Flow is a
temporary filling
material that sets with
curing light.
In case the cavity is not
permanently
restored, DiaTemp Flow
can be used
as a temporary restoration
until the
next appointment. | Clip Flow is a flowable,
light-curing material for
temporary fillings,
sealings and treatments.
Thanks to its elastic
consistency, the material
is easily removable, also
in case of undercuts.
Therefore, post-treatment
of the cavity is not
necessary. | Equivalent |
5
DiaDent Group International
Product Name: DiaTemp Flow
| Package | ·Syringe | •Syringe | Equivalent |
|---|---|---|---|
| Contents | •Disposable Tip | •Disposable Tip | |
| ·Protective Cap | |||
| Composition | ВНТ | ||
| Camphorquinone | |||
| Ethyl 4- | |||
| (N,Ndimethylamino)benzo | ВНТ | ||
| 2-hydroxyethyl metha- | |||
| crylate | |||
| Urethane Methacrylate | The main ingredients are | ||
| similar. Also, | |||
| biocompatibility and | |||
| performance tests | |||
| ate | Pyrogenic silicic acids | demonstrate that | |
| silica amorphous,fumed | catalyst | DiaTemp Flow and the | |
| predicate device are | |||
| substantially equivalent. | |||
| Performance | |||
| Standard | ISO4049 | ISO4049 | Equivalent |
| Conformance | |||
| Physical | |||
| and | |||
| Mechanical | |||
| Properties | -Sensitivity to ambient | ||
| light | |||
| -Depth of cure | |||
| -Shade & Colour stability | |||
| -Water sorption & | |||
| solubility | -Sensitivity to ambient | ||
| light | |||
| -Depth of cure | 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 above the comparison table. 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 | Light-cure with a polymerisation |
| light (minimum 500 mW/cm) a film | ||
| thickness up to 1 mm for 10s, (e.g. | ||
| in case of covering the gingival | ||
| margin), a thickness up to 5 mm for | ||
| 20 s and more than 5mm for 40s. |
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.