Adseal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Adseal is intended for use by qualified healthcare personnel trained in its use.

Device Description

Adseal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting. The device consists of tow components, the epoxy resin paste (Paste A) and the aminecontaining paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Adseal Root Canal Sealer, focusing on acceptance criteria and supporting studies:

This 510(k) summary is for a traditional medical device (a root canal sealer), and as such, the nature of its "acceptance criteria" and "study" is different from what one might expect for an AI/ML powered device. For such devices, "acceptance criteria" are typically based on established performance standards for the material, and the "study" is a series of laboratory tests demonstrating compliance with those standards. There is no AI component involved here, so questions related to AI performance, ground truth, expert adjudication, or MRMC studies are not applicable.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are derived from the international standard ISO 6876, "Dental root canal sealing materials." The 510(k) implicitly indicates that Adseal meets these criteria by stating "Similar Physical Properties" and then listing those properties under the Adseal column in the substantial equivalence comparison table.

Acceptance Criteria (from ISO 6876)	Reported Device Performance (Adseal)
Fluidity	Meets ISO 6876 requirements
Working Time	Meets ISO 6876 requirements
Film Thickness	Meets ISO 6876 requirements
Radiopacity	Meets ISO 6876 requirements
Solubility & Disintegration	Meets ISO 6876 requirements
Biocompatibility	Free from toxicity per ISO/TR 7405 Agar diffusion test

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 in a 510(k) summary for a material-based device. The "test set" would refer to the samples of the material tested in the laboratory. The document doesn't specify the number of samples or batches tested. The provenance is likely Korea, as the manufacturer is Meta Dental Co. 82-06 Grand Avenue Elmhurst, NY 11373 (US presence but likely manufacturing in Korea, common for medical device companies) and the ultimate letter is addressed to "Meta Biomed Company Limited." The testing would have been prospective to demonstrate compliance with the standard for the specific formulation.

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)

Not applicable. For a root canal sealer, "ground truth" refers to the objective physical and chemical properties of the material, as measured and evaluated according to the specified international standard (ISO 6876). This does not involve expert readers or diagnostic accuracy assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no adjudication method in the context of laboratory testing for material properties. The tests are designed to produce objective, measurable results.

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

Not applicable. This device is a material, not an AI-powered diagnostic tool. There are no "human readers" in this context, nor an AI component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance claims of this device is the objective measurements and observations performed in a laboratory setting according to the methodologies prescribed by ISO 6876 Dental root canal sealing materials. For biocompatibility, it's defined by the outcome of an "Agar diffusion test" per ISO/TR 7405.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" or associated ground truth establishment for this type of device.

Summary

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l 510(k) Summary
K042769

NOV 2 4 2004

1.1 Date of Summary Preparation: March 24, 2004 1.2 Manufacturers Contact Person: Jenny Sohn, Official Correspondent TEL (718)-639-7460
FAX (718)-639-7408 Meta Dental Co. 82-06 Grand Avenue Elmhurst, NY 11373
1.3 Name

Trade Name:	Adseal
Common Name:	Root Canal Sealer

1.4 Classification Name, Product Code, Class, Classification Reference:

Classification Name	Product Code	111Class	21CFR 8
Canal Filling Resin	VIC		070 7000
Koot	1, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2,		-- 3020

1.5 Standards/Special Controls:

ISO 6876 Dental root canal sealing materials.

1.6 Indications for Use:

Adseal is intended for use by qualified healthcare personnel trained in its use.

1.7 Device Description:

The device consists of tow components, the epoxy resin paste (Paste A) and the aminecontaining paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).

SKIS
DE
II
5

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Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator.

The Adseal device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.

1.8 Substantially Equivalent Commercially Available Devices:

The Adseal device is substantially equivalent to the predicate devices described herein with respect to indications for use, device design, materials, and method of manufacture:

Bi-Directional Spiral & Epoxy Root Canal Cement System K992727 Dentsply AH Plus Root Canal Sealer K960548 Dentsply AH 26 Root Canal Sealer (Pre- Amendment Device)

The predicate devices are commercially available and a marketed Class II devices indicated for use as a permanent root canal sealer.

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Substantial Equivalence Comparisor 1.9

Adseal is similar to commercially available device with respect to intended use, material, design and operational principles as follows

	Intended Use	Human Factors	Similar Physical Properties		Adseal	MDSBi-Directional Spiral& Epoxy Root CanalCement System	DentsplyAH 26	DentsplyAH Plus
Adseal	Permanent root canal sealer	For permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).Intended for use by qualified healthcare personnel trained in its use.	Mixed, two part system	ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity, Solubility & disintegration	Biocompatibility	Freedom from toxicity perISO/TR 7405 Agardiffusion test	Biocompatible	Biocompatible	Biocompatible
MDSBi-Directional Spiral & Epoxy Root Canal Cement System	Permanent root canal sealer	For permanent sealing of root canals following established endodontic procedures.Intended for use by qualified healthcare personnel trained in its use.	Mixed, two part system	ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity,	Design,Construction,Components	Biocompatible per ISO10993-11 Acuteintervenous applicationPremixed, two part paste,packaged in twocomponent plasticsyringe ready to bedispensed and mixed	Premixed, two partpowder/liquid-gel,packaged and ready tobe dispensed andmixed	Premixed, two partpowder/liquid-gel,packaged in a bottleand tube ready to bedispensed and mixed	Premixed, two partpaste, packaged in twoindividual tubes readyto be dispensed andmixed
Dentsply AH 26	Permanent root canal sealer	For permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).Intended for use by qualified healthcare personnel trained in its use.	Mixed, two part system	ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity,
Dentsply AH Plus	Permanent root canal sealer	For permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).Intended for use by qualified healthcare personnel trained in its use.	Mixed, two part system	ISO 6876 Fluidity, Working Time, Film Thickness, Radiopacity,

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1.10 Indications and Contraindications:

Relative indications and contraindications for Adseal and commercially available devices for similar intended uses are the same.

1.11 Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Meta Biomed Co., Ltd concludes that the new device, Adseal root canal sealer, is safe, effective and substantially equivalent to the predicate device as described herein.

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Image /page/5/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

Meta Biomed Company Limited C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548-1289

Re: K042769

Trade/Device Name: Adseal Root Canal Filling Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: November 10, 2004 Received: November 12, 2004

Dear Mr. Devine:

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. Devine

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/dsma/dsmamain.html

Sincerely yours,

Chris L

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): K042769

Device Name : Adseal Root Canal Filling

Indications for Use:

Adseal is intended for use by qualified healthcare personnel trained in its use.

Prescription Use
(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (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)

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

510(k) Number	R042769
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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.