510(k) · Cleared
ClearedO Butment ES Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O Co., Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 29, 1994 after a 755-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 29, 1994
- Review
- 755 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK923889 O Butment ES ImplantO Co., Inc. · 1994
- Descendant · cites it directly · 1 of its ownK973926 O Butment HS ImplantO Co., Inc. · 1998
- Descendant · cites it directly · 1 of its ownK961665 O Butment ET ImplantO Co., Inc. · 1996
- Descendant · cites it directly · 0 of its ownK011574 Uniplant Dental Implant SystemUniversal Implant Systems, Inc. · 2001
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923889 | O Butment ES Implant | O Co., Inc. | 1994 | — |
| +1 | K973926 | O Butment HS Implant | O Co., Inc. | 1998 | — |
| +1 | K961665 | O Butment ET Implant | O Co., Inc. | 1996 | — |
| +1 | K011574 | Uniplant Dental Implant System | Universal Implant Systems, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 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? (3)
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, K973926 (O Co., Inc., 1998) 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 | — |
https://510kreport.com/device/K923889 · printed Nov 5, 2026
Cite this page
510(k) Report. “K923889: O Butment ES Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K923889
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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