← Product Code [EAT](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT) · K970715 # SYSTEM B HEAT SOURCE (K970715) _Sybron Dental Specialties, Inc. · EAT · Apr 7, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT/K970715 ## Device Facts - **Applicant:** Sybron Dental Specialties, Inc. - **Product Code:** [EAT](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT.md) - **Decision Date:** Apr 7, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.1720 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## 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. ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 (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. SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVENUE, ORANGE, CALIFORIA 92667 (714) 516-7400 A SUBSIDIARY OF SYBRON INTERNATIONAL Printed on Recycled Paper {1} 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. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT/K970715](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAT/K970715) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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