510(k) · Cleared
ClearedCortex Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cortex Dental Implants Industries, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 29, 2017 after a 270-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Aug 29, 2017
- Review
- 270 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK163385 Cortex Dental Implant SystemCortex Dental Implants Industries, Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK182615 Surgikor Dental Implant SystemSurgikor, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK233271 OsseOne Dental Implant SystemSynoross Dba Osseone · 2025
- Descendant · 2 generations on · 0 of its ownK242217 Surcam Dental Implant SystemSurcam Medical Devices and Developments, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK240803 Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K182615Surgikor Dental Implant SystemSurgikor, LLC · 2019 · cites it directly3descendants
- K233271OsseOne Dental Implant SystemSynoross Dba Osseone · 2025 · 2 generations on0descendants
- K242217Surcam Dental Implant SystemSurcam Medical Devices and Developments, Ltd. · 2025 · 2 generations on0descendants
- K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K163385 | Cortex Dental Implant System | Cortex Dental Implants Industries, Ltd. | 2017 | — |
| +1 | K182615 | Surgikor Dental Implant System | Surgikor, LLC | 2019 | — |
| +2 | K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | 2025 | — |
| +2 | K242217 | Surcam Dental Implant System | Surcam Medical Devices and Developments, Ltd. | 2025 | — |
| +2 | K240803 | Surgikor Fixation One, Abutment Blanks and Abutments | Surgikor, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182615 | Surgikor Dental Implant System | 2019 | 3 |
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, K182615 (Surgikor, LLC, 2019) has gone furthest, with 3 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. 2017, this device’s year, is highlighted.
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?
Cortex Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K163385 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163385: Cortex 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/K163385
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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