510(k) · Cleared
ClearedOco Dental Implant (5.0MM Diameter)
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 Oct 9, 2002 after a 2-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Oct 9, 2002
- Review
- 2 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK023336 Oco Dental Implant (5.0MM Diameter)O Co., Inc. · 2002
- Descendant · cites it directly · 4 of its ownK090174 Tsi; EriOco Biomedical · 2009
- Descendant · cites it directly · 1 of its ownK110337 Universal Maxillary MolarOco Biomedical · 2012
- Descendant · 2 generations on · 0 of its ownK171197 Zuga Dental Implant SystemZuga Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK142846 BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK122198 6.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013
Most influential descendants
Showing 5 of 5 · See all- K090174Tsi; EriOco Biomedical · 2009 · cites it directly4descendants
- K110337Universal Maxillary MolarOco Biomedical · 2012 · cites it directly1descendant
- K171197Zuga Dental Implant SystemZuga Medical, Inc. · 2018 · 2 generations on0descendants
- K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc. · 2016 · 2 generations on0descendants
- K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023336 | Oco Dental Implant (5.0MM Diameter) | O Co., Inc. | 2002 | — |
| +1 | K090174 | Tsi; Eri | Oco Biomedical | 2009 | — |
| +1 | K110337 | Universal Maxillary Molar | Oco Biomedical | 2012 | — |
| +2 | K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | 2018 | — |
| +2 | K142846 | BBX1, BBX2, BBX1MO, BBX1MC | Globaldental, Inc. | 2016 | — |
| +1 | K122198 | 6.00MM X 6.00MM Macro External Implant System | Oco Biomedical | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 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? (5)
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, K090174 (Oco Biomedical, 2009) has gone furthest, with 4 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?
"0" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function,
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023336: Oco Dental Implant (5.0MM Diameter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023336
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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