510(k) · Cleared
ClearedSystem B Heat Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties, Inc. · EAT Tester, Pulp
Cleared on Apr 7, 1997 after a 39-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Apr 7, 1997
- Review
- 39 days
- Class
- Class II
- Product code
- EAT
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970715 System B Heat SourceSybron Dental Specialties, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK042870 Endo TwinnEndo Twinn B.V. · 2005
Most influential descendants
Showing 1 of 1 · See all- K042870Endo TwinnEndo Twinn B.V. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970715 | System B Heat Source | Sybron Dental Specialties, Inc. | 1997 | — |
| +1 | K042870 | Endo Twinn | Endo Twinn B.V. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EAT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Analytic Technology Corporation, Touch N' Heat Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042870 | Endo Twinn | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042870 (Endo Twinn B.V., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EAT devicesEAT Tester, Pulp: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EAT
FDA has decided no EAT device since 2007.
Median 510(k) review, days · EAT
Too few EAT 510(k)s in any year since 2007 to give a median.
Recalls per year · EAT
No recall names EAT since 2007.
Adverse event reports per year · EAT
2in 2024
MAUDE reports naming product code EAT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970715 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970715: System B Heat Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970715
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026