RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG

K992484 · Jordco, Inc. · KJJ · Oct 14, 1999 · DE

Device Facts

• Record ID: K992484
• Device Name: RCNG: ROOT CANAL NEGOTIATING GEL; MODEL RCNG
• Applicant: Jordco, Inc.
• Product Code: KJJ · DE
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

RCNG: Root Canal Negotiating Gel is used for instrument negotiation and debreedment of root canal systems during root canal therapy.

Device Story

RCNG (Root Canal Negotiating Gel) is a dental material used during root canal therapy. It facilitates instrument negotiation and debridement of root canal systems. Applied by dentists during endodontic procedures to assist in cleaning and shaping canals. Benefits include improved mechanical access and debris removal during instrumentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gel-based dental material for endodontic use. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for patients undergoing root canal therapy requiring instrument negotiation and debridement of root canal systems.

Submission Summary (Full Text)

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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 [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 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 [phone] or [phone] 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.

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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