510(k) · Cleared
ClearedEndo Twinn
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endo Twinn B.V. · EKM Gutta-Percha
Cleared on Jan 11, 2005 as substantially equivalent to K970715 (Sybron Dental Specialties, Inc., 1997) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jan 11, 2005
- Review
- 85 days
- Class
- Class I
- Product code
- EKM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963862 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963862 Touch N' HeatSybron Dental Specialties, Inc. · 1996
- This deviceK042870 Endo TwinnEndo Twinn B.V. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963862 | Touch N' Heat | Sybron Dental Specialties, Inc. | 1996 | — |
| 0 (this device) | K042870 | Endo Twinn | Endo Twinn B.V. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 EKM? 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? (2)
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 |
|---|---|---|---|
| * | K970715 | System B Heat SourceSummary page 1…he dental instrument heater marketed by Sybron functions in a manner similar to and is intended for the same use as the EndoTwinn. Predicate Devices: * Sybron, System B (K970715) HeatSource * Sybron, Touch 'n Heat (K963862) H. Device Testing Results and Conclusion The devise is tested thoroughly and i… | 1997 |
| * | K963862 | Touch N' HeatSummary page 1…n functions in a manner similar to and is intended for the same use as the EndoTwinn. Predicate Devices: * Sybron, System B (K970715) HeatSource * Sybron, Touch 'n Heat (K963862) H. Device Testing Results and Conclusion The devise is tested thoroughly and it complies to the standards for this class II… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All EKM devicesEKM Gutta-Percha: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKM
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · EKM
Too few EKM 510(k)s in any year since 2007 to give a median.
Recalls per year · EKM
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EKM
6in 2025
MAUDE reports naming product code EKM, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 5 |
| 2010 | 0 | — | 1 | 8 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the dental instrument heater - The EndoTwinn - is to provide continuous heat and/or vibration at the tip of a dental instrument. The EndoTwinn is designed for processing gutta percha (cutting softening, spreading, compacting) and cutting plastic handles of obturators during a root canal treatment The device may only be operated by dentists and endodontists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042870 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042870: Endo Twinn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042870
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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