510(k) · Cleared
ClearedSplint IT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeneric/Pentron, Inc. · ELS Splint, Endodontic Stabilizing
Cleared on Sep 24, 1997 after a 44-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Sep 24, 1997
- Review
- 44 days
- Class
- Class II
- Product code
- ELS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK972985 Splint ITJeneric/Pentron, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK123823 InterligAngelus Industria DE Productos Odontologicos · 2013
- Descendant · cites it directly · 0 of its ownK122348 Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS…Recherches Techniques Dentaires (R.T.D.) · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972985 | Splint IT | Jeneric/Pentron, Inc. | 1997 | — |
| +1 | K123823 | Interlig | Angelus Industria DE Productos Odontologicos | 2013 | — |
| +1 | K122348 | Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS Flow | Recherches Techniques Dentaires (R.T.D.) | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELS? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K123823 (Angelus Industria DE Productos Odontologicos, 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ELS devicesELS Splint, Endodontic Stabilizing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELS
FDA has decided no ELS device since 2007.
Median 510(k) review, days · ELS
Too few ELS 510(k)s in any year since 2007 to give a median.
Recalls per year · ELS
No recall names ELS since 2007.
Adverse event reports per year · ELS
1in 2025
MAUDE reports naming product code ELS, 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 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Splinting periodontially involved and mobile teeth to prevent movement.
To reinforce full denture and partial denture repairs.
As a matrix between abutment teeth for receiving a temporary replacement tooth.
As an aid in the reinforcement of temporary crowns and bridgework.
As a space maintainer for orthodontically involved teeth.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972985 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972985: Splint IT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972985
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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