510(k) · Cleared
ClearedThe 4.5MM Diameter Bicon Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bicon, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 11, 2000 after a 43-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Jan 11, 2000
- Review
- 43 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK994037 The 4.5MM Diameter Bicon Dental ImplantBicon, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK050586 Leone Implant SystemLeone S.P.A. · 2006
- Descendant · cites it directly · 1 of its ownK103810 KJ Submerged SystemKj Meditech Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK202046 LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK092674 Simpler Toadstool Mini ImplantPan Global Implant · 2009
- Descendant · 2 generations on · 0 of its ownK070483 Leone Monoimplant for O-Ring OverdentureLeone S.P.A. · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K050586Leone Implant SystemLeone S.P.A. · 2006 · cites it directly2descendants
- K103810KJ Submerged SystemKj Meditech Co., Ltd. · 2011 · cites it directly1descendant
- K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd. · 2022 · 2 generations on0descendants
- K092674Simpler Toadstool Mini ImplantPan Global Implant · 2009 · 2 generations on0descendants
- K070483Leone Monoimplant for O-Ring OverdentureLeone S.P.A. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994037 | The 4.5MM Diameter Bicon Dental Implant | Bicon, Inc. | 2000 | — |
| +1 | K050586 | Leone Implant System | Leone S.P.A. | 2006 | — |
| +1 | K103810 | KJ Submerged System | Kj Meditech Co., Ltd. | 2011 | — |
| +2 | K202046 | LOTA SLA Dental Implant System and LOTA HA Dental Implant System | Kj Meditech Co., Ltd. | 2022 | — |
| +2 | K092674 | Simpler Toadstool Mini Implant | Pan Global Implant | 2009 | — |
| +2 | K070483 | Leone Monoimplant for O-Ring Overdenture | Leone S.P.A. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2022 | 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? (6)
3 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, K050586 (Leone S.P.A., 2006) has gone furthest, with 2 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 4.5mm diameter implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridge work, partial dentures, and / or a single tooth replacement.
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/K994037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994037: The 4.5MM Diameter Bicon 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/K994037
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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