(56 days)
Not Found
Not Found
No
The description mentions a microprocessor for control and network communication, but there is no mention of AI, ML, or related concepts like algorithms that learn or adapt. The functions described (pulp testing via voltage, apex location via impedance) are based on direct electrical measurements, not complex data analysis or pattern recognition typically associated with AI/ML in medical devices.
No
The device is described as a "diagnostic unit" and its intended uses are to "test the vitality of a tooth" and "locate the apical foramen," which are diagnostic rather than therapeutic actions.
Yes
The 'Intended Use / Indications for Use' directly states that the device is "intended to be used in dentistry to test the vitality of a tooth and to locate the apical foramen of a root canal". These actions are diagnostic in nature, providing information about the patient's condition.
No
The device description clearly outlines hardware components such as a battery-operated unit, probes, clips, a remote satellite display, and a microprocessor controlling the device.
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 Elements Diagnostic Unit operates by applying electrical signals to the tooth or measuring electrical impedance within the root canal. These are direct measurements taken in vivo (within the living body), not tests performed on samples in vitro (outside the body).
- Intended Use: The intended use clearly states it's for testing the vitality of a tooth and locating the apical foramen in dentistry during root canal treatment. This is a clinical procedure performed directly on the patient.
Therefore, while it's a diagnostic device used in a clinical setting, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Elements Diagnostic Unit 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 diagnostic unit designed to be used in either of two modes, V as a pulp tester to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth), or A as an apex locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit uses a rechargeable battery pack, and can be used while the pack is charging. A remote satellite display that mirrors the values on the unit's graphic display can be attached to a chair, patient's bib or microscope for a more ergonomic monitoring of diagnostic status. To improve visibility and decrease eyestrain, the main body of the unit can be rotated from a vertical orientation to a 30° angle. The automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The endodontic diagnostic unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The remote satellite display 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
tooth, root canal
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): 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.
Sybron Endo/Analytic, Endo Analyzer, Model 8005, Modified
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.
Not Found
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).
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
JUN 1 9 2002
Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized font, with a curved line above the letters. The text "SYBRON DENTAL SPECIALTIES" is written in a simple font below the letters. The logo is black and white.
SYBRON DENTAL SPECIALTIES
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Ave Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: April 2002
Device Name:
- . Trade Name - Elements Diagnostic Unit
- Common Name Endodontic Diagnostic Unit ●
- Classification Name Pulp Tester, per 21 CFR § 872.1720 .
Devices for Which Substantial Equivalence is Claimed:
- Sybron Endo/Analytic, Endo Analyzer, Model 8005, Modified .
Device Description:
The device is a battery-operated, endodontic diagnostic unit designed to be used in either of two modes, V as a pulp tester to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth), or A as an apex locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit uses a rechargeable battery pack, and can be used while the pack is charging. A remote satellite display that mirrors the values on the unit's graphic display can be attached to a chair, patient's bib or microscope for a more ergonomic monitoring of diagnostic status. To improve visibility and decrease eyestrain, the main body of the unit can be rotated from a vertical orientation to a 30° angle. The automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The endodontic diagnostic unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The remote satellite display 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 Elements Diagnostic Unit is 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.
Substantial Equivalence:
Elements Diagnostic Unit is substantially equivalent to other legally marketed devices in the United States. Elements Diagnostic Unit functions in a manner similar to and is intended for the same use as the Endo Analyzer, Model 8005, Modified marketed by Sybron Endo/Analytic.
1717 West Collins Avenue, Orange, CA 92867 800-531-7824 714-515-7400
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2002
Sybron Endo/Analytic C/O Ms. Colleen Boswell Sybron Dental Specialties 1717 West Collins Avenue Orange, California 92867
Re: K021298
Trade/Device Name: Elements Diagnostic Unit Regulation Number: 872.1720 Regulation Name: Pulp Tester Regulatory Class: II Product Code: EAT Dated: April 23, 2002 Received: April 24, 2002
Dear Ms. Boswell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
2
Page 2 - Ms. Boswell
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely vours.
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
Koz1298
Section I
Indications for Use Statement
Ver/ 3 - 4/24/96
Sybron Endo/Analytic
0(k) Number (if known):
Device Name: Blements Diagnostic Unit
Indications For Use:
The Elements Diagnostic Unit is intended to be used in dentistry to test the vitality of a vooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devises 510lk) Number
EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER NEEDBD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801:109) (Optional Format 1-2-96)