(39 days)
Not Found
K/DEN Number and List: Not Found
No
The description focuses on a feedback control system for temperature regulation, which is a standard engineering technique and does not inherently imply AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is intended for tissue cauterization and coagulation, which are therapeutic interventions.
No
The intended use states that the device is used to "test tooth response to thermal stimulus," which is a diagnostic function, but it also includes "tissue cauterization and coagulation," which are therapeutic functions. Since the device has both diagnostic and therapeutic capabilities, it is not solely a diagnostic device.
No
The device description clearly states it is a "battery-operated dental instrument heater" with a "handpiece and cord assembly" and "dental instruments," indicating it is a physical hardware 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 System B HeatSource, Model 1005, is used directly on the tooth and tissue within the mouth. It applies heat for thermal testing and cauterization. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states its purpose is for testing tooth response to thermal stimulus and for tissue cauterization and coagulation, all of which are direct interventions or tests performed in vivo (within the living organism).
Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The System B HeatSource, Model 1005, is intended to be used in dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus and for tissue cauterization and coagulation.
Product codes
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Device Description
The device is a battery-operated dental instrument heater which is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip and the Cauterizing Tip, to test tooth response to thermal stimulus and for tissue cauterization and coagulation, respectively. The battery is fully rechargeable through the use of the plug-in charge adapter. The temperature is regulated by a feedback control system which automatically maintains a preset temperature for consistent results. The handpiece and cord assembly are completely removable. Both the handpiece and cord assembly and the dental instruments 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
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Indicated Patient Age Range
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Intended User / Care Setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Analytic Technology Corporation, Touch N' Heat
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
SYBRON
DENTAL SPECIALTIES, INC.
APR - 7 1997
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: February 1997
Device Name:
- Trade Name System B HeatSource .
- . Common Name - Dental Instrument Heater
- Classification Name Pulp Tester, per 21 CFR § 872.1720 ●
Devices for Which Substantial Equivalence is Claimed:
- Analytic Technology Corporation, Touch N' Heat .
Device Description:
The device is a battery-operated dental instrument heater which is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip and the Cauterizing Tip, to test tooth response to thermal stimulus and for tissue cauterization and coagulation, respectively. The battery is fully rechargeable through the use of the plug-in charge adapter. The temperature is regulated by a feedback control system which automatically maintains a preset temperature for consistent results. The handpiece and cord assembly are completely removable. Both the handpiece and cord assembly and the dental instruments used with the device are autoclavable.
Intended Use of the Device:
The intended use of the dental instrument heater is to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip and the Cauterizing Tip, to test tooth response to thermal stimulus and for tissue cauterization and coagulation.
Substantial Equivalence:
The dental instrument heater is substantially equivalent to several other legally marketed devices in the United States. The dental instrument heater marketed by Analytic Technology Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Analytic Technology Corporation.
1
Section 1 - Indications for Use
| 510(k) Number: | K970715 |
|---|---|
| ---------------- | --------- |
System B HeatSource, Model 1005 Device Name:
Indications for Use:
. . . . .
The System B HeatSource, Model 1005, is intended to be used in dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus and for tissue cauterization and coagulation.