(50 days)
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.
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.
The provided text is a 510(k) summary for a medical device called "Roeko Seal," a root canal filling material. It does not contain any information regarding acceptance criteria, device performance tables, study designs (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, ground truth types, or training set details.
The document primarily focuses on:
- Identification of the submitter and device.
- Classification of the device.
- Establishment of substantial equivalence to a predicate device (Lee Endo-Fill) based on technical characteristics (dimensional stability, flow, biocompatibility) and a general description of the material.
- FDA's response acknowledging the submission and determining substantial equivalence for the stated indications for use.
Therefore, I cannot provide the requested information from the given text. The text does not describe a study that validates the device's performance against specific acceptance criteria. Instead, it describes a regulatory submission seeking substantial equivalence to a pre-existing device.
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0CT 20 1998
Section 9
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.
- 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
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The name of this device is Root canal filling material. Its common name is Roeko Seal and its classification is root canal filling material.
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Roeko Seal is substantially equivalent to Lee Endo-Fill manufactured by Lee Pharmaceuticals.
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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.
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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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 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.