ROEKO SEAL

K983037 · Roeko Ulm, Roescheisen GmbH & Co. · KIF · Oct 20, 1998 · Dental

Device Facts

• Record ID: K983037
• Device Name: ROEKO SEAL
• Applicant: Roeko Ulm, Roescheisen GmbH & Co.
• Product Code: KIF · Dental
• Decision Date: Oct 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Roeko Seal root canal sealer is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.

Device Story

Roeko Seal is a permanent root canal filling material used by dentists during endodontic procedures. It is a silicone-based (polydimethylsiloxane) material containing zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid. The material is applied into the root canal to provide a permanent seal. It functions as a biocompatible filling agent with high dimensional stability and flow characteristics. The device is intended for professional use by clinicians in a dental office setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material composition similarities to the predicate device.

Technological Characteristics

Silicone-based (polydimethylsiloxane) root canal filling material. Composition includes zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid. Features high dimensional stability and flow. Application involves a specific mixing and polymerization process.

Indications for Use

Indicated for patients requiring permanent root canal obturation following vital extirpation or treatment of pulpal gangrene and temporary filling.

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

• Lee Endo-Fill (Lee Pharmaceuticals)

Submission Summary (Full Text)

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0CT 20 1998

Section 9

K983037

## 510 (k) Summary

This summary of 510 (k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 C.F.R. § 807.92.

1. The submitter of this premarket notification is: James Delaney, Associate EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord. MA 01742-5307 Tel .: (508) 371 - 0066 Fax. (508) 371 - 1676

This summary was prepared on August 27, 1998

2. The name of this device is Root canal filling material. Its common name is Roeko Seal and its classification is root canal filling material.

3. Roeko Seal is substantially equivalent to Lee Endo-Fill manufactured by Lee Pharmaceuticals.

4. Roeko Seal is a permanent root canal filling material, which is silicone based (Polydimethylsiloxane) and consists additionally of zircondioxide, paraffin-based oil silicone oil, hexachloroplatinic acid and silicic acid.

5. The technical characteristics are similar to those found with the predicate device Lee Endo-Fill, which is also silicone based. Dimensional stability, flow, and biocompatibility are very high for both materials. Differences are only in the polymerization process and the method of mixing/application.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 20 1998

Roeko GmbH & Company C/O Mr. James Delaney Associate EXPERTech Associates, Incorporated 100 Main Street, Suite 120 Concord, Massachusetts 01742-5307

K983037 Re : Trade Name: Roeko Seal Requlatory Class: II Product Code: KIF Dated: August 28, 1998 Received: August 31, 1998

Dear Mr. Delaney:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Delaney

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowsk Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K983037

Device Name: Roeko Seal

Indications for Use: The Roeko Seal root canal sealer is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dealed Shuppo
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number -

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use OR

(Optional Format 1-2-96)