(80 days)
RCNG: Root Canal Negotiating Gel is used for instrument negotiation and debreedment of root canal systems during root canal therapy.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the device "RCNG: Root Canal Negotiating Gel." It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, the provided text does not contain any information about:
- Acceptance criteria for device performance.
- A study that proves the device meets any acceptance criteria.
- Device performance data.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established for training or testing.
The document is a regulatory approval letter, not a device performance study report. Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is drawn with thick, black lines, giving it a bold and recognizable appearance.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1999
Mr. Hal J. Oien, DMD, President Jordco, Inc 595 NW 167th Avenue Beaverton, OR 97006
Re : K992484 RCNG: Root Canal Negotiating Gel Trade Name: Requlatory Class: Unclassified Product Code: KJJ July 23, 1999 Dated: Received: July 26, 1999
Dear Mr. Oien:
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 qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation 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
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obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 diagnostic 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 ons regardination" (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,
Patrica Cucaidiffer
Timothy A. Ulatowski 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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Indications for Use Statement: 18
510(k) Number (if known): _ _________________
RCNG: Root Canal Negotiating Gel Device Name:
Indications For Use:
RCNG: Root Canal Negotiating Gel is used for instrument negotiation and debreedment of root canal systems during root canal therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Dunne
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number I9921184
Jordco, Inc. * Hal J. Oien, DMD * 595 NW 1674 Ave * Beaverton * OR * 97006 1-503-351-3904* 1-503-531-3757 FAX A971253: Page 38
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