DenFil™ Etchant-37 is an etching agent consists of 37% phosphoric acid formulations thickened with natural polymer. It is classified into tooth shade resin material, 21 CFFR Section 872.3690, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.

AI/ML Overview

The provided text describes a 510(k) submission for a dental etching agent, DenFil™ Etchant-37, and focuses on demonstrating its substantial equivalence to a predicate device, K-ETCHANT GEL. This type of submission does not typically involve a clinical study with detailed acceptance criteria and performance metrics in the way a novel device might. Instead, the focus is on showing similarity to an already approved device.

Here's an analysis based on the provided information, noting where specific details are absent due to the nature of a 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from "Similarities" and "Safety/Performance")	Reported Device Performance (DenFil™ Etchant-37)
Device Characteristics (Main Material, Chemical Composition, Use Concept)	Same as predicate device (K-ETCHANT GEL). This is a qualitative assessment.
Mechanical Properties (pH, Adhesion, Viscosity)	Similar to predicate device (K-ETCHANT GEL). This implies values within an acceptable range, though the specific range or actual values are not reported.
Safety Tests (Biocompatibility)	Performed to ensure compliance with applicable International and US regulations. Specific results or acceptance limits are not detailed in this summary but would have been part of the full submission.
Performance Validation	Subjected to extensive validation prior to release. Specific performance metrics are not detailed, but likely confirm its ability to effectively etch enamel and dentin for adhesive restorations.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a comparison study demonstrating substantial equivalence to the predicate device, K-ETCHANT GEL (K062409).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of a clinical trial with human subjects for performance evaluation as described. The "test set" here refers to samples of the etching agent itself (DenFil™ Etchant-37) used for characterization and comparison to the predicate device. The specific number of samples for pH, adhesion, and viscosity testing is not provided in this summary.
Data Provenance: The tests (physical property measurements, biocompatibility) would have been performed by Vericom Co. Ltd. or its contracted labs. The data would be prospective in the sense that DenFil™ Etchant-37 was manufactured and then tested. The country of origin for the testing itself is likely South Korea, where Vericom Co. Ltd. is based.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. For a dental etching agent seeking 510(k) clearance based on substantial equivalence, "ground truth" isn't established by expert consensus on clinical outcomes in the same way it would be for a diagnostic AI device. Instead, the "truth" is based on established scientific principles for chemical composition, physical properties, and safety standards for dental materials.
Qualifications of Experts: Not specified. Any experts involved would be material scientists, chemists, or toxicologists assessing the properties and safety of the dental material.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no human interpretation of results requiring adjudication in this type of submission. The results of the physical and chemical tests are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., medical imaging AI) to compare the performance of human readers with and without AI assistance. DenFil™ Etchant-37 is a dental material, not a diagnostic AI tool.

6. Standalone Performance Study (Algorithm Only)

Standalone Study: No, a standalone performance study in the context of an "algorithm only" is not applicable as DenFil™ Etchant-37 is a chemical product, not a software algorithm. Its performance is evaluated through material science testing.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device is based on established scientific and engineering principles for dental materials. This includes:
- Chemical composition standards: Ensuring the phosphoric acid concentration is 37% and the thickening agent is a natural polymer as specified.
- Physical property measurements: Objective measurements of pH, adhesion strength to enamel/dentin, and viscosity.
- Biocompatibility standards: Compliance with international and US regulations for materials that come in contact with human tissue.
- Performance relative to a predicate device: The predicate device (K-ETCHANT GEL) serves as the benchmark for "acceptable" performance and safety.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. DenFil™ Etchant-37 is a manufactured chemical product, not a machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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Ko80265

000015

2007 2008

Vericom Co. Ltd.

Healthy and beautiful teeth with Vericom

Page 1 of 2

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: September 1, 2007

Company making the submission:

	Submitter
Name	VERICOM Co., Ltd.
Address	#606, 5th Dongyoung Venturestel
	199-32, Anyang 7-Dong, Manan-Gu
	Anyang-Si, Gyeonggi-Do,
	Republic of Korea 430-817
Phone	+82 31 441-2881
Fax	+82 31 441-2883
Contact	Myung-Hwan Oh
Internet	mh-oh@hanmail.net

2, Device:

Proprietary Name - DenFil™ Etchant-37 Common Name - Etching agent Classification Name - Material, Tooth Shade, Resin

Predicate Device:

K-ETCHANT GEL, KURARAY MEDICAL INC, K062409

4. Description:

DenFil™ Etchant-37 is an etching agent consists of 37% phosphoric acid formulations
thickened with natural polymer. It is classified into tooth shade resin material, 21 CFFR Section 872.3690, because it is a device intended to be painted on the interior of a
prepared cavity of a tooth to improve retention of a restoration.

Indication for use:

Etching the enamel and dentine for adhesive restorations.

に、そのあると、そのため、このと、この、ここで、

606,50 Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea

Image /page/0/Picture/19 description: The image shows a logo for Vericom Dental Materials. The logo is black and white and features the word "VERICOM" in a stylized font. Below the word "VERICOM" are the words "Dental materials" in a smaller font. The logo is simple and professional, and it is likely used to promote Vericom Dental Materials and its products.

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Page 2 of 2

Vericom Co. Ltd. Company Comments of Children Comments of

Healthy and beautiful teeth with Vericom

6. Review:

DenFil™ Etchant-37 has the same device characteristics as the predicate device; main material, chemical composition, and use concept.

DenFil™ Etchant-37 has the similar mechanical properties as the predicate device; pH, adhesion and viscosity.

DenFil™ Etchant-37 has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable Internation and US regulations.

7. Conclusions :

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Vericom Co., Ltd. concludes that DenFam Etchant-37 is safe and effective and substantially equivalent to predicate devices as described herein.

1. Vericom Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

CI Car 2019 Catalia 2011 - 14

606,5m Dongyoung Venturestel, 199-32, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do 430-817, Korea

Image /page/1/Picture/14 description: The image shows a logo for a company called "VERICOM Dental materials". The logo is in black and white and features the company name in a stylized font. The words "Dental materials" are written in a smaller font below the company name. The logo has a curved shape.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is composed of thick, black lines.

FEB - 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vericom Company, Limited C/O Mr. Morten S. Christensen Responsible Third Party Official Underwriters Laboratories Incorporated 455 East Trimble Road San Jose, California 95131-1230

Re: K080265

Trade/Device Name: DenFil™ Etchant-37 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 22, 2008 Received: February 1, 2008

Dear Mr. Christensen:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Christensen

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Submission - DenFill™ Etchant-37

510(k) Number K080305

Device Name: DenFil™ Etchant-37

Indication for use:

Etching the enamel and dentine for adhesive restorations. .

Prescription Use (Per 21CFR801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vericom Co., Ltd.

Susan Ruoves

Division Sign-Off)

Jivision of Anesthesists

Indication for use Page # 1 of 1

Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices

10(k) Number: TO 800

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.