REALSEAL XT SEALER

K102163 · Kerr Corporation · KIF · Oct 16, 2010 · Dental

Device Facts

• Record ID: K102163
• Device Name: REALSEAL XT SEALER
• Applicant: Kerr Corporation
• Product Code: KIF · Dental
• Decision Date: Oct 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

RealSeal XT Sealer is a self-etching, dual-cure methacrylate/epoxy resin root canal sealant used for permanent obturation. Supplied in a 4 ml dual-barrel syringe, it is applied by a dentist during root canal procedures. The material can be mixed via an auto-mixing tip or manually on a pad. It functions by adhering to tooth structure and root canal points without requiring separate etchants, primers, or adhesives. The dual-cure mechanism allows for self-curing or light-curing to facilitate immediate hardening and cleaning. By providing a secure seal in combination with root canal points, it aids in the permanent obturation of the root canal system.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility studies and bench testing comparing working time, water solubility, and bond strength to predicate devices.

Technological Characteristics

Self-etching methacrylate/epoxy resin paste-paste formulation. Dual-cure (self-cure and light-cure). Packaged in 4 ml dual-barrel syringe with auto-mixing tip. No etchant, primer, or adhesive required.

Indications for Use

Indicated for permanent root canal obturation and sealing in combination with root canal points or an obturator for dental patients requiring root canal therapy.

Regulatory Classification

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.

Predicate Devices

• SE Epiphany Root Canal Sealant
• AH Plus Root Canal Sealer (Dentsply)

Submission Summary (Full Text)

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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 [phone] - Phone [phone] - 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:

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.

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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 [phone] or [phone] 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