SYSTEM B HEAT SOURCE

K970715 · Sybron Dental Specialties, Inc. · EAT · Apr 7, 1997 · Dental

Device Facts

• Record ID: K970715
• Device Name: SYSTEM B HEAT SOURCE
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EAT · Dental
• Decision Date: Apr 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Battery-operated dental instrument heater; provides continuous heat to Hot Pulp Test Tip or Cauterizing Tip. Used by dentists for thermal pulp testing and tissue cauterization/coagulation. Features rechargeable battery, plug-in charge adapter, and feedback control system for preset temperature maintenance. Handpiece, cord assembly, and tips are autoclavable. Output is thermal energy at instrument tip; clinician observes patient response to thermal stimulus or performs cauterization/coagulation directly.

Clinical Evidence

No clinical data provided; device relies on technological similarity to predicate.

Technological Characteristics

Battery-operated dental instrument heater; feedback control system for temperature regulation; autoclavable handpiece, cord, and tips; rechargeable battery with plug-in adapter.

Indications for Use

Indicated for use in dentistry for testing tooth response to thermal stimulus and for tissue cauterization and coagulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Analytic Technology Corporation, Touch N’ Heat

Submission Summary (Full Text)

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SYBRON
DENTAL SPECIALTIES, INC.
K970715
APR - 7 1997

# Section III - 510(k) Summary of Safety and Effectiveness

## Submitter:

Sybron Dental Specialties, Inc.
1717 W. Collins Avenue
Orange, California 92867
[phone] - Phone
[phone] - 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.

SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVENUE, ORANGE, CALIFORIA 92667 [phone]
A SUBSIDIARY OF SYBRON INTERNATIONAL
Printed on Recycled Paper

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Section I - Indications for Use

510(k) Number: K970715

Device Name: System B HeatSource, Model 1005

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.