APEX LOCATOR BINGO-1020

K992233 · Dent Corp. Research & Development · LQY · Nov 30, 1999 · DE

Device Facts

• Record ID: K992233
• Device Name: APEX LOCATOR BINGO-1020
• Applicant: Dent Corp. Research & Development
• Product Code: LQY · DE
• Decision Date: Nov 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

BINGO-1020 is a modern device for precise apex localization during root channel treatment. BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.

Device Story

BINGO-1020 is an electronic apex locator used by dentists during root canal procedures. The device measures electrical impedance between an endodontic file inserted into the root canal and a mucosal electrode. It processes these impedance signals to determine the file's position relative to the apical foramen. The device features a graphic display that provides real-time visual feedback of the file's depth with 0.1mm precision, functioning in both wet and dry canal conditions. By accurately identifying the apex, the device assists the clinician in determining the appropriate working length for root canal instrumentation, thereby helping to prevent over-instrumentation and improving the quality of the root canal treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic apex locator; utilizes impedance-based sensing to detect file position within root canals. Features a graphic display for visual output. Operates in wet or dry canal environments. Precision rated at 0.1mm.

Indications for Use

Indicated for precise apex localization during root canal treatment in patients requiring endodontic procedures.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 30 1999

Mr. David Albelda President Dent Corp™ Research & Development 7-11 S. Broadway White Plains, NY 10601

K992233 Re : Apex Locator Bingo-1020 Trade Name: Regulatory Class: Unclassified Product Code: LQY Dated: October 4, 1999 Received: October 6, 1999

Dear Mr. Albelda:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 requlations 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) 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

{1}------------------------------------------------

Page 2 - Mr. Albelda

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Che nol 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 marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (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 requlation entitled, "Misbranding by reference to ene regaracion Shorologi Maximally 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

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

Enclosure

{2}------------------------------------------------

Paqe of I

S10(k) NUMBER (IF KNOWN): K992233

DEVICE NAME:

INDICATIONS FOR USE:

BINGO-1020 is a modern device for precise apex localization during root channel treatment.

BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use y (Per 21 CFR 801.109)

Divisir

Div

OR

Over-The-Counter-U (Optional Format

Susen Runne

(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

| 510(k) Number | Rax0233 |
|---------------|---------|
|---------------|---------|

Control,

ces

· ·