The intended use of the endodontic analyzer is to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

The Endo Analyzer, Model 8005, Modified is intended to be used in dentistry to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

Device Description

The device is a battery-operated, endodontic analyzer which is designed to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth) and to locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit is battery operated using six (6) 1.5 volt size AA alkaline batteries. An automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The unit may be used in either of two modes, V.S. as a pulp tester or A.F. as an apex locator. The endodontic analyzer is controlled by a microprocessor and the handpiece and cord assembly are completely removable. The probes, lip clips and file clips used with the device are autoclavable.

AI/ML Overview

This 510(k) summary (K990225) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) summary for a modified endodontic analyzer device (Endo Analyzer, Model 8005, Modified). It primarily focuses on demonstrating substantial equivalence to a predicate device based on similar function and intended use.

Here's what the document does include and what it lacks in relation to your request:

Information Present:

Device Name: Endo Analyzer, Model 8005, Modified
Intended Use: To test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.
Predicate Device: Analytic Endodontics, Endo Analyzer, Model 8005
Submission Date: January 1999

Missing Information (Crucial for your request):

The document does not contain any details about acceptance criteria, performance studies, or clinical data. This type of information is typically found in the full 510(k) submission, not necessarily in the summary provided to the FDA for public reference. Therefore, I cannot construct the table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement.

To obtain the requested information, you would need to access the complete 510(k) submission for K990225, which would include performance data, clinical testing protocols, and results.

Summary

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2/25/99

Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the logo, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple, sans-serif font. There is also a handwritten number 'ka90225' on the top left corner of the image.

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: January 1999

Device Name:

Trade Name Endo Analyzer, Model 8005, Modified .
Common Name Endodontic Analyzer ●
Classification Name Pulp Tester, per 21 CFR § 872.1720 ●

Devices for Which Substantial Equivalence is Claimed:

Analytic Endodontics, Endo Analyzer, Model 8005 .

Device Description:

Intended Use of the Device:

The intended use of the endodontic analyzer is to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.

Substantial Equivalence:

The endodontic analyzer is substantially equivalent to several other legally marketed devices in the United States. The modified design of the Endo Analyzer, Model 8005, functions in a manner similar to and is intended for the same use as the original Endo Analyzer, Model 8005 designed by Analytic Endodontics.

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Image /page/1/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a stylized human figure or a bird in flight. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 1999

Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

Re : K990225 Endo Analyzer, Model 8005, Modified Trade Name: Regulatory Class: II Product Code: EAT January 21, 1999 Dated: January 25, 1999 Received:

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice 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 The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Fegulations, 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 Failure to comply with the GMP verify such assumptions. regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any 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.

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Page 2 - Ms. Boswell

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
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) 638-2044 or (301) 443-6597 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

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510(k) Number (if known): _ k 990225

Dovice Name: ENDO ANALYZER, MODEL 8005, MODIFIED

Indications For Usc:

510(k) Number:

Endo Analyzer, Model 8005, Modified Device Name:

Indications for_Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Syper Quaser

Division Sign-Off) ivision of Dental, Infection Control. and General Hospital Device 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Formal 1-2-96)

Regulation Number and Section

§ 872.1720 Pulp tester.

(a)
Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.