(89 days)
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No
The description mentions a microprocessor for control but does not include any terms or descriptions indicative of AI/ML, such as algorithms, learning, training data, or performance metrics typically associated with AI/ML models.
No.
The device is used for diagnostic purposes (testing vitality of a tooth, locating apical foramen) and does not directly provide therapy.
Yes
The device is described as an "endodontic analyzer" that is designed to "test the vitality of a tooth" and "locate the apical foramen," which are diagnostic functions in dentistry.
No
The device description explicitly states it is a "battery-operated, endodontic analyzer" and mentions hardware components like batteries, a handpiece, cord assembly, vitality scanner tips, and a lip clip. This indicates it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, the Endo Analyzer, Model 8005, 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.
- Endo Analyzer Function: The Endo Analyzer directly interacts with the tooth and root canal within the patient's body to assess tooth vitality and locate the apical foramen. It does not analyze samples taken from the body.
Therefore, the Endo Analyzer falls under the category of a medical device used for diagnosis and treatment in vivo (within the living body), not an in vitro diagnostic device.
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, 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 (comma separated list FDA assigned to the subject device)
EAT
Device Description
The device is a battery-operated, endodontic analyzer which is designed to test the vitality of a tooth and to locate the apical foramen of a root canal during root canal treatment. The unit is battery operated using three (3) 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 vitality scanner 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 handpiece and cord assembly, including the vitality scanner tips and lip clip used with the device, are autoclavable.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tooth, root canal
Indicated Patient Age Range
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Intended User / Care Setting
dentistry / Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Sybron Dental Specialties, Inc. The word "SYBRON" is in large, bold, sans-serif font at the top. Below that, "DENTAL SPECIALTIES, INC." is in a smaller, bold, sans-serif font.
Image /page/0/Picture/1 description: The image shows the text "DEC - 8 1997" on the top line. Below that is the text "KA73439". The text appears to be handwritten in black ink on a white background. The text is slightly blurry.
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
September 1997 Date Summary Prepared:
Device Name:
- Trade Name Endo Analyzer, Model 8005 .
- Common Name Endodontic Analyzer .
- Classification Name Pulp Tester, per 21 CFR § 872.1720 .
Devices for Which Substantial Equivalence is Claimed:
- Analytic Technology Corporation, Apex Finder A.F.A. .
- Analytic Technology Corporation, Vitality Scanner .
Device Description:
The device is a battery-operated, endodontic analyzer which is designed to test the vitality of a tooth and to locate the apical foramen of a root canal during root canal treatment. The unit is battery operated using three (3) 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 vitality scanner 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 handpiece and cord assembly, including the vitality scanner tips and lip clip 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 Vitality Scanner and Apex Finder A.F.A. marketed by Analytic Technology Corporation function in a manner similar to and are intended for the same use as the product manufactured by Analytic Technology Corporation.
Image /page/0/Picture/20 description: The image shows a recycling symbol next to the words "Printed on Recycled Paper". The recycling symbol is a universal symbol that indicates that a product is made from recycled materials. The text indicates that the paper is made from recycled materials.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 1997
Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867
K973439 Re: Endo Analyzer, Model 8005 Trade Name: Regulatory Class: II Product Code: EAT September 8, 1997 Dated: Received: September 10, 1997
Dear Ms. Boswell:
We have reviewed your Section 510(k) notification of intent to we have telewoa referenced above and we have determined the marros 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 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) 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 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 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 requlation (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 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,
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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Section I - Indications for Use
- Rangala 510(k) Number:
Device Name: Endo Analyzer, Model 8005
Indications for Use:
The Endo Analyzer, Model 8005, 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.
(Division Sign-Off) Parailor Scott . Division of Dental, Infection Control, and General Hospital Devices
510(k) Number_4973439