510(k) · Cleared
ClearedKLS Martin IPS Preprosthetic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · ELE Implant, Subperiosteal
Cleared on Jul 8, 2022 as substantially equivalent to K801208 (Colmed, Ltd., 1980) after a 526-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Jul 8, 2022
- Review
- 526 days
- Class
- Class II
- Product code
- ELE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K801208 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK801208 Hollow Basket Titanium Dental ImplantColmed, Ltd. · 1980
- This deviceK210228 KLS Martin IPS PreprostheticKLS-Martin L.P. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801208 | Hollow Basket Titanium Dental Implant | Colmed, Ltd. | 1980 | — |
| 0 (this device) | K210228 | KLS Martin IPS Preprosthetic | KLS-Martin L.P. | 2022 | — |
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 ELE? 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 |
|---|---|---|---|
| * | K801208 | Hollow Basket Titanium Dental ImplantSummary page 4…, subperiosteal (21 CFR 872.3645) Regulatory Class: II Product Code: ELE Predicate Device: Hollow Basket Titanium Dental Implant (K801208) Reference Devices: Pacific Implants Intraosseous Dental Implant (K813227) KLS Martin In… | 1980 |
| † | K813227 | Intraosseous Dental Implant | 1981 |
| † | K191028 | KLS Martin Individual Patient Solutions | 2019 |
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?
- Its one ancestor has no recall.
How does its category compare?
All ELE devicesELE Implant, Subperiosteal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ELE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · ELE
Too few ELE 510(k)s in any year since 2007 to give a median.
Recalls per year · ELE
No recall names ELE since 2007.
Adverse event reports per year · ELE
1in 2018
MAUDE reports naming product code ELE, 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 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KLS Martin IPS Preprosthetic Implant is a subperiosteal implant composed of titanium intended to construct patient specific prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for multi-unit prostheses, such as dentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210228: KLS Martin IPS Preprosthetic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210228
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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