510(k) · Cleared
ClearedThe 6.0 X 8.0MM Dental Implant System
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 Sep 17, 1997 after an 82-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Sep 17, 1997
- Review
- 82 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK972417 The 6.0 X 8.0MM Dental Implant SystemBicon, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK103810 KJ Submerged SystemKj Meditech Co., Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK072595 Omni-TightBasic Dental Implant Systems, Inc. · 2008
- 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 ownK082749 Omni-TightBasic Dental Implant Systems, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K103810KJ Submerged SystemKj Meditech Co., Ltd. · 2011 · cites it directly1descendant
- K072595Omni-TightBasic Dental Implant Systems, Inc. · 2008 · cites it directly1descendant
- K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd. · 2022 · 2 generations on0descendants
- K082749Omni-TightBasic Dental Implant Systems, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972417 | The 6.0 X 8.0MM Dental Implant System | Bicon, Inc. | 1997 | — |
| +1 | K103810 | KJ Submerged System | Kj Meditech Co., Ltd. | 2011 | — |
| +1 | K072595 | Omni-Tight | Basic Dental Implant Systems, Inc. | 2008 | — |
| +2 | K202046 | LOTA SLA Dental Implant System and LOTA HA Dental Implant System | Kj Meditech Co., Ltd. | 2022 | — |
| +2 | K082749 | Omni-Tight | Basic Dental Implant Systems, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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? (4)
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, K103810 (Kj Meditech Co., Ltd., 2011) has gone furthest, with 1 descendant 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 6.0 x 8.0mm implant is 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 bridgework, partial
dentures, 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/K972417 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972417: The 6.0 X 8.0MM Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972417
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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