K-ETCHANT GEL is an etching agent consists of 40 % phosphoric acid aqueous solution and colloidal silica. It is classified into resin tooth honding agent, 21 CFR Section 872.3200, 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

This document is a 510(k) summary for K-ETCHANT GEL, an etching agent. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, most of the requested information cannot be found in the provided text.

Here is what can be extracted and what is not available:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary aims to demonstrate substantial equivalence, not to report specific performance metrics against pre-defined acceptance criteria from a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions K-ETCHANT GEL has been a component of CLEARFIL PHOTO BOND and is now being marketed independently. It asserts that the applicant device is "essentially the same" as the K-ETCHANT GEL in CLEARFIL PHOTO BOND, implying prior established safety and effectiveness. No new test set data is presented for the independent device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As no specific test set study is detailed, there's no mention of experts or ground truth establishment in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. The device is an etching agent, not an AI-powered diagnostic tool, so an MRMC study or AI assistance is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a chemical etching agent, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.

8. The sample size for the training set
This information is not applicable/not provided. The device is a chemical product, not a system that uses a training set for machine learning.

9. How the ground truth for the training set was established
This information is not applicable/not provided.

Summary based on the provided text:

The document is a 510(k) summary for K-ETCHANT GEL, an etching agent composed of 40% phosphoric acid aqueous solution and colloidal silica.

Overall Study Information:
The "study" presented is not a new clinical performance study but rather a demonstration of substantial equivalence to existing legally marketed predicate devices. The primary assertion is that K-ETCHANT GEL, when marketed independently, is essentially the same as its previous formulation within the CLEARFIL PHOTO BOND system and shares the same intended use.

Predicate Devices:

CLEARFIL PHOTO BOND (510(k) Numbers: K943165, K012432 (modification))
PULPDENT ETCH-RITE ROYALE (510(k) Number: K031915)

Claim of Substantial Equivalence:
The applicant states that the safety and effectiveness of the independent K-ETCHANT GEL are substantially equivalent to the K-ETCHANT GEL component in CLEARFIL PHOTO BOND and to other single-item etching agents like PULPDENT ETCH-RITE ROYALE. This means the existing evidence for the predicate devices and the prior use of K-ETCHANT GEL within CLEARFIL PHOTO BOND are being leveraged to support its independent marketing. No new clinical or performance data against specific acceptance criteria for the standalone device are detailed in this summary.

Summary

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uraray

Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters appear to be 'K062409'. The writing is in black ink on a white background. The characters are somewhat stylized and have a slightly irregular appearance.

August 16, 2006 Date:

510(k) Summar

NOV - 8 2006

510(k) owner (submitter)

1) Name	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
3) Contact person	Michio TakigawaQuality Assurance Department
4) Contact person in U.S.	Koji NishidaKURARAY AMERICA, INC.600 Lexington Avenue, 26th FloorNew York, NY 10022Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676Fax: (212)-867-3543
2. Name of Device
1) Trade / Proprietary name	K-ETCHANT GEL
2) Classification name	Resin tooth bonding agent

Resin tooth bonding agent (21 CFR section 872.3200. Product code: KLE)

Common narne

Etching, agent

Predicate device

The aim of this submission is to market K-ETCHANT GEL, which has been one of the components in CLEARFIL PHOTO BOND, independently as a single device "K-ETCHANT GEL".

1) CLEARFIL PHOTO BOND	510(k) Number:	K943165 K012432 (modification)
	Product Code:21 CFR Section:Applicant:	KLE872.3200KURARAY MEDICAL INC.
2) PULPDENT ETCH-RITE ROYALE	510(k) Number:Product Code:21 CFR Section:Applicant:	K031915KLE872.3200PULPDENT CORPORATION

Description of device

1. Intended use
  K-ETCHANT GEL is intended to be used for the following indication;
Etching the enamel and dentine for adhesive restorations

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6. Substantial equivalence

K-ETCHANT GEL has been one of the components in, and will be marketed independently as a single device "K-ETCHATN GEL" from CLEANFIL PHOTO BOND. The applicant device, is essentially the same as K-ETCHANT GEL in CLEARFIL PHOTO BOND that its safety and effectiveness are substantially equivalent to this predicate device. It shares the same intended use with other legally marketed devices of this kind marketed single item such as PULPDENT ETCH-RITE ROYALE.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical, Incorporated C/O Mr. Koji Nishida General Manager Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022

NOV -8 2006

Re: K062409

Trade/Device Name: K-ETCHANT GEL Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 16, 2006 Received: August 24, 2006

Dear Mr. Nishida:

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. Nishida

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.

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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Indications for Use

510(k) Number (if known): ر

Device Name: K-ETCHANT GEL

Indications for Use:

Etching the enamel and dentine for adhesive restorations.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/CPR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use N/A (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control. D

510(k) Number: K062409

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.