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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "DiaTemp Flow," a temporary crown and bridge resin. It does not describe an AI/ML powered device, therefore, the request cannot be fully satisfied as it asks for information pertaining to AI/ML powered devices.

However, I can extract the information that is present and relevant to the "acceptance criteria and the study that proves the device meets the acceptance criteria" for the DiaTemp Flow device.

Acceptance Criteria and Device Performance (Non-AI Device)

The DiaTemp Flow device is a temporary filling material and its performance is evaluated against material properties and biocompatibility standards, rather than diagnostic accuracy or sensitivity/specificity metrics typically associated with AI assistance. The acceptance criteria are implicit in the conformance to the specified ISO standards and the comparison with the predicate device.

Here's a table based on the provided document:

Acceptance Criteria (Implied by Standards & Predicate)	Reported Device Performance (DiaTemp Flow)
Conformance to ISO 4049:2009 (Dentistry Polymer-based restorative materials)	Demonstrated conformance
Conformance to ISO 7405:2009 (Dentistry Evaluation of biocompatibility)	Demonstrated conformance
Conformance to ISO 10993-1:2009 (Biocompatibility Risk Management)	Demonstrated conformance
Conformance to other ISO 10993 series (Biocompatibility Tests)	Demonstrated conformance
Similar Indications for Use as Predicate Device (K153493)	Indications for Use are "Equivalent" (Minor differences in coverage of "block-out material for retentive areas")
Similar Description as Predicate Device	Description is "Equivalent"
Similar Packaging and Contents as Predicate Device	Packaging and Contents are "Equivalent"
Similar Main Composition as Predicate Device	Main ingredients are "similar" (Slightly different in specific components like 2-hydroxyethyl methacrylate and Urethane Methacrylate, but biocompatibility and performance confirmed)
Similar Sensitivity to ambient light as Predicate Device	"homogeneous" (Equivalent)
Similar Depth of cure as Predicate Device	"More than 1.5mm" (Equivalent to predicate's light-cure specifications for various depths and times)
Similar Period of Use as Predicate Device	"Prolonged exposure(B)" (Equivalent)
Biocompatibility as Predicate Device	"Biocompatible" (Equivalent)
Use (Prescription/Hospital) as Predicate Device	"Prescription/Hospital" (Equivalent)

Regarding AI/ML Specific Questions (Not Applicable to this Device):

The provided document specifically states:
"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:" (followed by a list of ISO standards).

Therefore, the following information is not applicable or available in the provided document for "DiaTemp Flow" as it is a material-based device, not an AI/ML software device:

Sample size used for the test set and the data provenance: Not applicable. Performance demonstrated through non-clinical testing against standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is based on standard scientific measurements, not expert consensus on medical images/data.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a material device, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a material device.
The type of ground truth used: For material properties, it's based on scientific measurements and adherence to ISO standards. For biocompatibility, it's based on in-vitro and in-vivo tests as per ISO 10993 series.
The sample size for the training set: Not applicable. There is no training set for this type of device.
How the ground truth for the training set was established: Not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K192022

Device Name DiaTemp Flow

Indications for Use (Describe)

1. Temporary inlay and onlay treatments of the cavity.
1. Sealing of openings for implant screws.
1. Relining material for temporary crowns and bridges.
1. Covering of the gingival margin.
1. Fixing of resin matrix during filling placement.

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

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

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

1. Temporary inlay and onlay treatments of the cavity.
1. Sealing of openings for implant screws.
1. Relining material for temporary crowns and bridges.
1. Covering of the gingival margin.
1. Fixing of resin matrix during filling placement.

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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	DiaDentGroupInternational	VOCO GmBH
Device Name	DiaTemp Flow	Clip Flow
Indications forUse	1. Temporary inlay andonlay treatments of thecavity.2. Sealing of openings forimplant screws.3. Relining material fortemporary crowns andbridges.4. Covering of the gingivalmargin.5. Fixing of resin matrixduring filling placement.	1. Temporary inlay andonlay treatments of thecavity.2. Sealing of openings forimplant screws.3. Relining material fortemporary crowns andbridges.4. Block-out material forretentive areas in thedental arch, e.g. beforetaking impressions.5. Covering of the gingivalmargin.6. Fixing of resin matrixduring filling placement.	Equivalent
Description	DiaTemp Flow is atemporary fillingmaterial that sets withcuring light.In case the cavity is notpermanentlyrestored, DiaTemp Flowcan be usedas a temporary restorationuntil thenext appointment.	Clip Flow is a flowable,light-curing material fortemporary fillings,sealings and treatments.Thanks to its elasticconsistency, the materialis easily removable, alsoin case of undercuts.Therefore, post-treatmentof the cavity is notnecessary.	Equivalent

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DiaDent Group International

Product Name: DiaTemp Flow

Package	·Syringe	•Syringe	Equivalent
Contents	•Disposable Tip	•Disposable Tip
	·Protective Cap
Composition	ВНТCamphorquinoneEthyl 4-(N,Ndimethylamino)benzo	ВНТ2-hydroxyethyl metha-crylateUrethane Methacrylate	The main ingredients aresimilar. Also,biocompatibility andperformance tests
	ate	Pyrogenic silicic acids	demonstrate that
	silica amorphous,fumed	catalyst	DiaTemp Flow and thepredicate device aresubstantially equivalent.
Performance
Standard	ISO4049	ISO4049	Equivalent
Conformance
PhysicalandMechanicalProperties	-Sensitivity to ambientlight-Depth of cure-Shade & Colour stability-Water sorption &solubility	-Sensitivity to ambientlight-Depth of cure	Equivalent
Period of Use	Prolonged exposure(B)(exceed 24 hours but not30 days)	Prolonged exposure(B)(exceed 24 hours but not30 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 polymerisationlight (minimum 500 mW/cm) a filmthickness up to 1 mm for 10s, (e.g.in case of covering the gingivalmargin), a thickness up to 5 mm for20 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.

Regulation Number and Section

§ 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.