510(k) · Cleared
ClearedLaminoss Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impladent, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on May 18, 1999 after a 271-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- May 18, 1999
- Review
- 271 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK982925 Laminoss Dental ImplantImpladent, Ltd. · 1999
- Descendant · cites it directly · 5 of its ownK033392 Immediate Stabilizing Implant (Isi)O Co., Inc. · 2003
- Descendant · 2 generations on · 4 of its ownK090174 Tsi; EriOco Biomedical · 2009
- Descendant · cites it directly · 4 of its ownK083544 Kat Implant SystemKat Implants, LLC · 2009
- Descendant · 2 generations on · 3 of its ownK101201 Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0…Kat Implants, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK122664 Zuga Dental Implant SystemZuga Medical, Inc. · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K033392Immediate Stabilizing Implant (Isi)O Co., Inc. · 2003 · cites it directly5descendants
- K090174Tsi; EriOco Biomedical · 2009 · 2 generations on4descendants
- K083544Kat Implant SystemKat Implants, LLC · 2009 · cites it directly4descendants
- K101201Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model…Kat Implants, LLC · 2011 · 2 generations on3descendants
- K122664Zuga Dental Implant SystemZuga Medical, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982925 | Laminoss Dental Implant | Impladent, Ltd. | 1999 | — |
| +1 | K033392 | Immediate Stabilizing Implant (Isi) | O Co., Inc. | 2003 | — |
| +2 | K090174 | Tsi; Eri | Oco Biomedical | 2009 | — |
| +1 | K083544 | Kat Implant System | Kat Implants, LLC | 2009 | — |
| +2 | K101201 | Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0… | Kat Implants, LLC | 2011 | — |
| +2 | K122664 | Zuga Dental Implant System | Zuga Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (10)
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, K033392 (O Co., Inc., 2003) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The LAMINOSS® Osteocompressive Implant System consists of a one-piece and two-piece immediately-loaded screw implants for the maxillary and mandibular arches to support fixed or removable prostheses.
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/K982925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982925: Laminoss Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982925
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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