Well-Pex™ is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectorny, or for apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

Device Description

Well-Pex™ is a temporary root canal filling material after pulpectomy, or for apexogenesis or velifeex is a temporaly root contriming material and the treatment of infected root canals. apexinciation. It is also docu as a good finance shows excellent radiopacity and prevention of microbial contamination. It has high fluidity and excellent accessibility into the root canal. Well-Pex™ is a premixed paste as a non-setting material and is very stable without any soliditication or separation. And it is packaged in a convenient syringe with disposable tips, a plastic holder and disposable tip cap.

AI/ML Overview

The document provided (K080266) is a 510(k) summary for a dental root canal filling material called Well-Pex™. It is not related to a medical device that uses artificial intelligence or requires a clinical study with acceptance criteria for performance metrics like sensitivity, specificity, or F1 score.

The 510(k) summary for Well-Pex™ focuses on demonstrating substantial equivalence to a predicate device (Metapex) based on similar technological characteristics, physical properties (flow, film thickness, radiopacity, solubility, disintegration), and indications for use. It mentions safety tests including biocompatibility, but these are general compliance statements rather than detailed performance studies with specific statistical acceptance criteria.

Therefore, most of the information requested in your prompt (e.g., table of acceptance criteria, sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this type of device submission.

Here's how the provided information relates to your questions, noting where the information is absent:

A table of acceptance criteria and the reported device performance
- Not applicable in the context of AI device performance metrics. This document does not present quantitative performance measures like sensitivity, specificity, or AUC against specific acceptance criteria for diagnostic accuracy.
- The document states: "Well-Pex™ has the similar physical properties as the predicate device; flow, film thickness, Radiopacity, slubility and disintegration." This implies the device met internal performance standards comparable to the predicate for these physical properties, but specific numerical acceptance criteria or performance values are not provided in this summary.
Sample sizes used for the test set and the data provenance
- Not applicable. This submission doesn't describe a "test set" in the context of an AI/diagnostic algorithm. It refers to "extensive safety, performance, and product validations," but details about sample sizes or data provenance for these validations are not included in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" establishment in the sense of expert consensus on diagnostic outcomes as the device is a dental material, not a diagnostic algorithm.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This is not an AI or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for a dental filling material would involve material science standards and biocompatibility. The summary states "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." The specific standards or methods for establishing this "ground truth" are not detailed in this summary document.
The sample size for the training set
- Not applicable. This device does not involve machine learning or a "training set."
How the ground truth for the training set was established
- Not applicable.

In summary, the provided document is a 510(k) premarket notification for a traditional medical device (dental filling material), not an AI/ML-based device. Therefore, the detailed requirements for describing AI device validation studies, including acceptance criteria, sample sizes, and ground truth establishment, are not present in this document. The "study that proves the device meets the acceptance criteria" is implicitly the "extensive safety, performance, and product validations" and biocompatibility tests, which demonstrate substantial equivalence to the predicate device based on similar characteristics and properties, rather than a clinical trial validating diagnostic performance metrics.

Summary

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K080266

Vericom Co. Ltd. ンク

Healthy and beautiful teeth with Vericom

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: ________________________________________________________________________________________________________________________________________________________________________

Company making the submission:

	Submitter
Name	VERICOM Co., Ltd.
Address	#606, 5th Dongyoung Venturestel199-32, Anyang 7-Dong, Manan-GuAnyang-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

FEB - 6

Device :

Proprietary Name - Well-Pex™ Common Name - Root canal filling Materials Classification Name - Resin, Root Canal Filling

Predicate Device :

Metapex, META BIOMED CO. LTD. K032603

4. Description :

··············································································································································································

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

Image /page/0/Picture/17 description: The image shows the logo for Vericom Dental Materials. The logo consists of the word "VERICOM" in bold, sans-serif font, arched upwards. Below the word "VERICOM" are the words "Dental materials" in a smaller, serif font. The logo is black and white.

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Vericom Co. Ltd.

Healthy and beautiful teeth with Vericom

Indication for use :

Review :

Well-Pex™ has the similar technological characteristics as the predicate device; device design, appearance, main materials and indication for use.

Well-Pex™ has the similar physical properties as the predicate device; flow, film thickness, Radiopacity, slubility and disintegration.

Well-Pex™ 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 International and US regulations.

1. Conclusions :
  ln 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 Well-Pex™ 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

606,56 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". Below the logo, the words "Dental materials" are printed in a smaller font. The logo is black and white and has a stylized design.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around it. Inside the circle is a stylized image of an eagle with its wings spread.

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: K080266

Trade/Device Name: Well-PexTM Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF 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,

CluR

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) Number K ( -

Device Name: Well-Pex™

Indication for use:

Prescription Use OR Over-The-Counter Use (Per 21CFR801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vericom Co., Ltd

Indication for use Page # 1 of 1

Suen Ringer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: Y020666

00-MB-F0031 - Rev. 2.1

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.