TOUCH N' HEAT

K963862 · Sybron Dental Specialties, Inc. · EAT · Dec 2, 1996 · Dental

Device Facts

• Record ID: K963862
• Device Name: TOUCH N' HEAT
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EAT · Dental
• Decision Date: Dec 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1720
• Device Class: Class 2

Intended Use

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.

Device Story

Battery-operated or wall-adapter-powered dental instrument; provides continuous heat to Hot Pulp Test Tip. Clinician uses device by heating tip, applying heat to tooth via medium (e.g., softened gutta percha ball dipped in talcum powder or Vaseline). Patient response to thermal stimulus evaluated by clinician to assess pulp health or inflammation. Used in dental clinic setting.

Clinical Evidence

No clinical data provided; device relies on established use of thermal pulp testing.

Technological Characteristics

Battery-operated (Models 5001, 5004) or wall-adapter-powered (Model 5002). Features rechargeable battery system. Utilizes Hot Pulp Test Tip for thermal transfer. Class II device per 21 CFR § 872.1720.

Indications for Use

Indicated for testing tooth response to thermal stimulus to evaluate pulp health or inflammation in dental patients.

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

• Union Broach, a division of Moyco Industries, Inc., Odontotest Thermal Pulp Tester

Submission Summary (Full Text)

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DEC - 2 1996
K963862

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: 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.

SYBR
1717 W. COLLINS AVENUE, ORANGE, CALIFORNIA 92867 [phone]
A SUBSIDIARY OF INTERNATIONAL