(69 days)
The intended use of the device is to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus.
The device, which is battery-operated (Model 5001 and 5004) or powered by a wall adapter (Model 5002), is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus. The battery operated models are fully rechargeable through the use of the plug-in charge adapter. The Hot Pulp Test Tip is heated to the desired temperature. A medium, such as a ball of softened gutta percha, is used to transfer the heat from the Hot Pulp Test Tip to the tooth. The gutta percha ball is dipped into talcum powder or Vaseline to prevent it from sticking to the tooth. The Hot Pulp Test Tip is placed in firm contact with the tooth, ensuring that a good contact is established. The patient's response to the heat is evaluated by the clinician to determine whether the pulp is healthy or inflamed.
The provided text describes a "Touch n' Heat" dental instrument heater and its intended use as a thermal pulp tester. However, it does not contain any information regarding acceptance criteria, device performance metrics, study details (sample sizes, ground truth, expert qualifications, adjudication methods), or any comparative effectiveness studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them because the necessary information is absent from the input.
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Image /page/0/Picture/0 description: The image shows the logo for "DENTAL SPECIALTIES, INC.". The text is in a simple, sans-serif font and is arranged in two lines. The logo is black and white and appears to be a scan of a document.
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters and numbers. The sequence appears to be "KA638662". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters connected and others distinct.
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: September 1996
Device Name:
- Trade Name Touch n' Heat .
- Common Name Dental Instrument Heater .
- . Classification Name - Pulp Tester, per 21 CFR § 872.1720
Devices for Which Substantial Equivalence is Claimed:
- Union Broach, a division of Moyco Industries, Inc., Odontotest Thermal Pulp Tester .
Device Description:
The device, which is battery-operated (Model 5001 and 5004) or powered by a wall adapter (Model 5002), is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus. The battery operated models are fully rechargeable through the use of the plug-in charge adapter. The Hot Pulp Test Tip is heated to the desired temperature. A medium, such as a ball of softened gutta percha, is used to transfer the heat from the Hot Pulp Test Tip to the tooth. The gutta percha ball is dipped into talcum powder or Vaseline to prevent it from sticking to the tooth. The Hot Pulp Test Tip is placed in firm contact with the tooth, ensuring that a good contact is established. The patient's response to the heat is evaluated by the clinician to determine whether the pulp is healthy or inflamed.
Intended Use of the Device:
The intended use of the device is to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus.
Substantial Equivalence:
The device is substantially equivalent to other legally marketed devices in the United States. The thermal pulp tester marketed by Union Broach, a division of Moyco Industries, Inc., is intended for the same use as the product manufactured by Analytic Technology Corporation.
§ 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.