(31 days)
Not Found
No
The device description focuses on electrical signal processing and impedance measurement controlled by a microprocessor, with no mention of AI or ML concepts.
No.
The device is used for diagnostic purposes (testing vitality and locating apical foramen) rather than for treating a condition or altering the body's function.
Yes
The device is described as an "endodontic analyzer" intended to "test the vitality of a tooth" and "locate the apical foramen of a root canal". These functions involve assessing a patient's condition to help diagnose or guide treatment, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "battery-operated, endodontic analyzer" and details hardware components like batteries, a microprocessor, handpiece, cord assembly, probes, lip clips, and file clips.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is used in dentistry to:
- Test the vitality of a tooth (by passing a signal through the tooth).
- Locate the apical foramen of a root canal (by measuring impedance within the root canal).
- No Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the tooth and root canal in situ.
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics. It is a medical device used for diagnostic and procedural purposes within the oral cavity.
N/A
Intended Use / Indications for Use
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.
Product codes
EAT
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.
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
dentistry
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)
Analytic Endodontics, Endo Analyzer, Model 8005
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
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.
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.
1
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.
2
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
3
Page / of /
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:
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.
(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)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)