RealSeal XT Sealer is intended for permanent obturation of root canals of teeth in combination with root canal points. The subject device is a self-etch methacrylate/epoxy resin root canal sealant in a catalyst/base paste formulation, which combines the methacrylate and epoxies resin chemistry. Due to its self-etching and adhering properties, RealSeal XT Sealer does not require the use of an etchant, primer or adhesive to achieve its intended function. It has also been designed for dual cure capabilities. That is, it not only self-cures after mixing the catalyst and base parts in a specific time period, but it can also be light cured by the doctor if there is a need to see an immediate hardening of the material, which facilitates the immediate cleaning of the material after a root canal filling procedure. RedSeal XT Sealer will be packaged in a 4 ml dual-barrel syringe for both the catalyst and base parts. The material can be mixed using an auto-mixing tip attached to the syringe or the material can be mixed by hand on a paper pad, if desirable.

AI/ML Overview

I'm sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a root canal sealant (RealSeal XT Sealer) and focuses on demonstrating substantial equivalence to predicate devices, rather than outlining specific acceptance criteria or detailed study results.

Here's why the requested information cannot be extracted:

Acceptance Criteria and Reported Performance: The document mentions "bench testing used to evaluate the performance characteristics of RealSeal XT Sealer compared to the predicate devices. The characteristics evaluated include working time, water solubility and bond strength." However, it does not provide a table of specific acceptance criteria (e.g., "working time must be between X and Y minutes") nor the reported device performance values against those criteria. It only states that the performance is "substantially equivalent" to predicate devices based on these tests.
Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Details, Training Set Details: These are all aspects related to a clinical study or a more detailed performance evaluation, typically seen with AI/ML devices or more complex diagnostic tools. The provided text describes a dental material and its bench testing for physical properties, not a clinical study involving human subjects or AI algorithms that would require such details.

The document is a submission for a medical device that demonstrates equivalence through biocompatibility and comparative bench testing of physical properties, not a study evaluating human reading performance or AI algorithm accuracy.

Summary

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OCT 1 6 2010

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: July 2010

Device Name:

Trade Name - RealSeal XT Sealer
. Common Name - Root Canal Sealant
. Classification Name - Root Canal Filling Resin, per 21 CFR § 872.3820

Devices for Which Substantial Equivalence is Claimed:

Pentron Clinical, SE Epiphany Root Canal Sealant
. Dentsply, AH Plus Root Canal Sealer

Device Description:

base parts. The material can be mixed using an auto-mixing tip attached to the syringe or the material can be mixed by hand on a paper pad, if desirable.

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Intended Use of the Device:

RedSeal XT Sealer is indicated for permanent root canal obturation and sealing, in combination with root canal points or an obturator.

Substantial Equivalence:

RealSeal XT Sealer is substantially equivalent to two other legally marketed devices in the United States. RealSeal XT Sealer functions in a manner similar to and is intended for the same use as the SE Epiphany Root Canal Sealant (currently marketed by SybronEndo as RealSeal SE Root Canal Sealant) and as AH Plus Root Canal Sealer, marketed by Dentsply. With the exception of one component, the components used in the RealSeal XT Sealer are commonly used in a variety of other dental resin composite products. Further details regarding the subject component is provided in this submission.

RedSed XT Sealer is a self-etch methacrylate/epoxy resin root canal sealant in a catalyst/base paste-paste formulation, which combines a modified methacrylate chemistry based upon SE Epiphany Root Canal Sealant and epoxies resin chemistry based upon AH Plus Root Canal Sealer . Due to its self-etching and adhering properties, RealSeal XT Sealer is similar to SE Epiphany Root Canal Sealant in that it does not require the use of an etchant, primer or adhesive to achieve its intended function. The bonding capabilities to both tooth structure and composite gutta percha point materials have improved in RedSeal XT Sedler; however, the application procedures and indications have not changed.

Biocompatibility studies have been completed, which demonstrates that RealSeal XT Sealer is safe for its intended use.

This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of RealSeal XT Sealer compared to the predicate devices. The characteristics evaluated include working time, water solubility and bond strength.

Based upon the biocompatibility tests and bench testing, the clinical performance of RealSeal XT Sealer is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

OCT 1 6 2010

Re: K102163

Trade/Device Name: RealSeal XT Sealer Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Codes: KIF Dated: July 26, 2010 Received: August 2, 2010

Dear Ms. Garman:

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. 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.

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Page 2 - Ms. Garman

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Anthony D. Watson, B.S., M.S., M.B.A. 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): K102163

OCT 1 6 2010

Device Name: RealSeal XT Sealer

Indications For Use:

RealSeal XT Sealer is indicated for permanent root canal obturation and sealing, in combination with root canal points or an obturator.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Turner

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

510(k) Number: K102163

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.