(80 days)
Not Found
Not Found
No
The provided text describes a root canal negotiating gel and does not mention any AI or ML components.
No
The device is a gel used for root canal procedures, which is a consumable material rather than a device that directly performs a therapeutic function. It aids in the procedure but is not a standalone therapeutic device.
No
The device, RCNG: Root Canal Negotiating Gel, is used for "instrument negotiation and debreedment of root canal systems," which are therapeutic actions, not diagnostic ones. It helps with the physical treatment of the root canal, rather than identifying a condition or disease.
No
The device description is not found, but the intended use clearly describes a "Root Canal Negotiating Gel," which is a physical substance used in a medical procedure, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "instrument negotiation and debreedment of root canal systems during root canal therapy." This describes a procedure performed on the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: While the description is "Not Found," the intended use clearly places the device's function within a clinical procedure rather than a laboratory test.
- Anatomical Site: The anatomical site is "root canal systems," which are part of the patient's body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is directly related to a therapeutic procedure within the patient's body.
N/A
Intended Use / Indications for Use
RCNG: Root Canal Negotiating Gel is used for instrument negotiation and debreedment of root canal systems during root canal therapy.
Product codes
KJJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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Page 2 - Mr. Oien
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
2
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