510(k) · Cleared
ClearedSwissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/Opar,Opb 8,10,12,14/OP2.3D/OP2.8D,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Core-Vent Corp. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 30, 2000 after a 102-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 395 later devices descend from it.
- Decided
- Oct 30, 2000
- Review
- 102 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
395 later devices descend from it, 2 citing it directly.
- This deviceK002188 Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB…Core-Vent Corp. · 2000
- Descendant · cites it directly · 222 of its ownK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- Descendant · 2 generations on · 211 of its ownK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- Descendant · 3 generations on · 202 of its ownK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- Descendant · cites it directly · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- Descendant · 2 generations on · 183 of its ownK062030 US SystemOsstem Implant Co., Ltd. · 2006
Showing 5 of 395 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 395 · See all- K051576Avana Dental Implant SystemOsstem Co., Ltd. · 2005 · cites it directly222descendants
- K062051SS SystemOsstem Implant Co., Ltd. · 2006 · 2 generations on211descendants
- K063861GS SystemOsstem Implant Co., Ltd. · 2007 · 3 generations on202descendants
- K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · cites it directly187descendants
- K062030US SystemOsstem Implant Co., Ltd. · 2006 · 2 generations on183descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002188 | Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB… | Core-Vent Corp. | 2000 | — |
| +1 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| +2 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| +3 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| +1 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +2 | K062030 | US System | Osstem Implant Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 12 | 0 |
| 2009 | 9 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 14 | 0 |
| 2013 | 18 | 0 |
| 2014 | 17 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 19 | 0 |
| 2018 | 19 | 0 |
| 2019 | 17 | 0 |
| 2020 | 37 | 0 |
| 2021 | 25 | 0 |
| 2022 | 34 | 0 |
| 2023 | 42 | 0 |
| 2024 | 38 | 0 |
| 2025 | 30 | 0 |
| 2026 | 20 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (395)
See all 3952 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, K051576 (Osstem Co., Ltd., 2005) has gone furthest, with 222 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 | — |
https://510kreport.com/device/K002188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002188: Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/Opar,Opb 8,10,12,14/OP2.3D/OP2.8D,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002188
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026