# K970715: System B Heat Source

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Apr 7, 1997 after 39 days
- Product code: EAT (Tester, Pulp)
- Device class: 2
- Regulation: 21 CFR 872.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Analytic Technology Corporation, Touch N' Heat: named in the summary without a submission number

## Most influential descendants
- K042870: Endo Twinn (2005), 0 descendants of its own

## 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 page: https://510kreport.com/device/K970715
Methodology: https://510kreport.com/methodology