510(k) · Cleared
ClearedMti-MP Transitional Implants and Modular Prosthetic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentatus USA, Ltd. · ELS Splint, Endodontic Stabilizing
Cleared on Jul 26, 1996 as substantially equivalent to K834363 (C.B.S. Biotechnics, Inc., 1984) after an 85-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.
- Decided
- Jul 26, 1996
- Review
- 85 days
- Class
- Class II
- Product code
- ELS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K834363 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK834363 Endix Radicular Bioceramic PinC.B.S. Biotechnics, Inc. · 1984
- This deviceK961704 Mti-MP Transitional Implants and Modular Prosthetic SystemDentatus USA, Ltd. · 1996
- Descendant · cites it directly · 0 of its ownK072917 JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008
Most influential descendants
Showing 1 of 1 · See all- K072917JJG Evolution Orthodontic Implant SystemOdontit S.A. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K834363 | Endix Radicular Bioceramic Pin | C.B.S. Biotechnics, Inc. | 1984 | — |
| 0 (this device) | K961704 | Mti-MP Transitional Implants and Modular Prosthetic System | Dentatus USA, Ltd. | 1996 | — |
| +1 | K072917 | JJG Evolution Orthodontic Implant System | Odontit S.A. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 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? (3)
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 |
|---|---|---|---|
| * | K834363 | Endix Radicular Bioceramic PinSummary page 1…odontic splints manufactured before May 28, 1976, and to devices cleared by the 510(k) process such as the Biotechnics, Inc.,"Radicular Bio-Ceramic Pin," cleared under K-834363 and assigned the code ELS. VIl. Technology: These devices are manufactured from the titanium materials proved effective by the a… | 1984 |
| * | — | Pre-amendment endodontic splints classified under 21 CFR 872.3890 Named without a submission number | |
| * | — | Endodontic splints manufactured before May 28, 1976 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 |
|---|---|---|---|
| K072917 | JJG Evolution Orthodontic Implant System | 2008 | 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?
- Its one ancestor has no recall.
- Of its descendants, K072917 (Odontit S.A., 2008) 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 | — |
https://510kreport.com/device/K961704 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961704: Mti-MP Transitional Implants and Modular Prosthetic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961704
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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