ROOT CANAL XR

K083062 · S & C Polymer GmbH · KIF · Mar 12, 2009 · Dental

Device Facts

• Record ID: K083062
• Device Name: ROOT CANAL XR
• Applicant: S & C Polymer GmbH
• Product Code: KIF · Dental
• Decision Date: Mar 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

System for cleansing, sealing and filling of canals consisting of 3 products: Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes for use in the effective cleansing of the root canal during root canal preparation. DC Canal Seal SE is a simple to use selfetching dual cure sealer for conditioning of root canals and for sealing of side tubuli. DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates. All directions and all labels are marked with Caution: Federal Law restricts this device to sale by or on the order of a dentist - For dental use only

Device Story

Root Canal XR is a three-component endodontic system used by dentists for root canal preparation and obturation. The system includes: 1) Canal Cleaner, a carbamide-peroxide and EDTA-based gel for canal cleansing; 2) DC Canal Seal SE, a self-etching dual-cure sealer for conditioning and sealing side tubuli; and 3) DC Root XR, a dual-cure flowable methacrylate-based filling material. The components are applied manually by the dentist during clinical endodontic treatment to clean, condition, and seal the root canal space, facilitating effective filling and preventing microleakage.

Clinical Evidence

Bench testing only.

Technological Characteristics

System consists of three chemical components: carbamide-peroxide/EDTA gel (cleanser), self-etching dual-cure resin sealer, and dual-cure flowable methacrylate-based filling material. Delivered via syringes. No electronic or software components.

Indications for Use

Indicated for cleansing, sealing, and filling of root canals during endodontic procedures. For use by dentists only.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 1 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Christian Boettcher Regulatory Compliance Officer S & C Polymer Silicon- und Composite Spezialitaten GmbH Robert-Bosch- Strasse 5 D-25335 Elmshorn GERMANY

Re: K083062

Trade/Device Name: Root Canal XR Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: February 23, 2009 Received: February 25, 2009

Dear Dr. Boettcher:

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 - Dr. Boettcher

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Ranoc

Ginette Y. Michaud, M.D. Acting 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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## 9. Statement of Indication for Use

510(k) Number (if known):

K083062

Device Name:

Root Canal XR

Indications for Use: root

Concerned products:

DC Canal Seal SE:

DC Root XR:

Canal Cleaner:

System for cleansing, sealing and filling of canals consisting of 3 products:

Canal Cleaner is a carbamide-peroxide and EDTA-containing gel in syringes for use in the effective cleansing of the root canal during root canal preparation.

DC Canal Seal SE is a simple to use selfetching dual cure sealer for conditioning of root canals and for sealing of side tubuli.

DC Root XR is a dual cure flowable root canal sealing and filling material based on methacrylates.

All directions and all labels are marked with

Caution: Federal Law restricts this device to sale by or on the order of a dentist - For dental use only

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pinover

KOS 3060

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

510(k) Number:

Over-The-Counter Use

Prescription Use: _ V

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