510(k) · Cleared
ClearedSurgikor Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgikor, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Jul 8, 2019 as substantially equivalent to K163385 (Cortex Dental Implants Industries, Ltd., 2017) after a 290-day review. Its family tree reaches back 1 generation to 2017. 3 later devices descend from it.
- Decided
- Jul 8, 2019
- Review
- 290 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K163385 (2017). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK163385 Cortex Dental Implant SystemCortex Dental Implants Industries, Ltd. · 2017
- This deviceK182615 Surgikor Dental Implant SystemSurgikor, LLC · 2019
- Descendant · cites it directly · 0 of its ownK233271 OsseOne Dental Implant SystemSynoross Dba Osseone · 2025
- Descendant · cites it directly · 0 of its ownK242217 Surcam Dental Implant SystemSurcam Medical Devices and Developments, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240803 Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC · 2024
Most influential descendants
Showing 3 of 3 · See all- K233271OsseOne Dental Implant SystemSynoross Dba Osseone · 2025 · cites it directly0descendants
- K242217Surcam Dental Implant SystemSurcam Medical Devices and Developments, Ltd. · 2025 · cites it directly0descendants
- K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K163385 | Cortex Dental Implant System | Cortex Dental Implants Industries, Ltd. | 2017 | — |
| 0 (this device) | K182615 | Surgikor Dental Implant System | Surgikor, LLC | 2019 | — |
| +1 | K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | 2025 | — |
| +1 | K242217 | Surcam Dental Implant System | Surcam Medical Devices and Developments, Ltd. | 2025 | — |
| +1 | K240803 | Surgikor Fixation One, Abutment Blanks and Abutments | Surgikor, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163385 | Cortex Dental Implant SystemSummary page 6…ing to ISO 17665-1 and -2. Materials used in the product meet ASTM F136. Endotoxin testing according to USP 161 was conducted. Primary Predicate: Cortex Dental Implants K163385 Reference Devices: Cortex Dental Implants K090709 AB Dental Implants K132125 & K181381 and Osstem K161604 Substan… | 2017 |
| † | K090709 | Cortex Dental Implant System | 2009 |
| † | K132125 | A.B. Dental Devices Dental Implants System | 2014 |
| † | K181381 | A.B. Dental Devices Dental Implants System | 2018 |
| † | K161604 | OSSTEM Implant System | 2016 |
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?
- Its one ancestor has no recall.
- Of its descendants, K233271 (Synoross Dba Osseone, 2025) has gone furthest, with 0 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. 2019, 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?
Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182615: Surgikor Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182615
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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