510(k) · Cleared
ClearedCORE1 Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cybermed, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 7, 2022 as substantially equivalent to K153639 (Dentis Co., Ltd., 2016) after a 366-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Jan 7, 2022
- Review
- 366 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894595 (1990). 98 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- 2 generations backK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
- 1 generation backK153639 OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016
- This deviceK210039 CORE1 Implant SystemCybermed, Inc. · 2022
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 10 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 9 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 8 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 7 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 4 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 3 generations backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- 2 generations backK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
- 1 generation backK153639 OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016
- This deviceK210039 CORE1 Implant SystemCybermed, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −10 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −9 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −8 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −7 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −4 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −3 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| −2 | K142313 | OneQ-SL Implant System | Dentis Co., Ltd. | 2015 | — |
| −1 | K153639 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2016 | — |
| 0 (this device) | K210039 | CORE1 Implant System | Cybermed, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 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 |
|---|---|---|---|
| * | K153639 | OneQ-SL s-Clean Implant SystemSummary page 4…umber 872.3640 ·Class: 2 ·Primary Product Code: DZE ·Secondary Product Code: NHA III. PREDICATE DEVICE Primary predicate device K153639, OneQ-SL s-Clean Implant System, Dentis Co., Ltd. Reference device K161244, s-Clean OneQ-SL Narrow Implant Syst… | 2016 |
| † | K161244 | s-Clean OneQ-SL Narrow Implant System | 2016 |
| † | K190837 | Internal Hex Implant System | 2020 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K172100 | URIS OMNI System | 2018 |
| † | K161689 | OSSTEM Implant System - Abutment | 2017 |
| † | K140507 | Hiossen Prosthetic System | 2014 |
| † | K173570 | SD Abutment | 2019 |
| † | K173141 | CSM Submerged3-L Implant System | 2018 |
| † | K181138 | IS-III active System | 2018 |
| † | K072642 | Biomet 3I Dental Abutments and Restorative Components | 2007 |
| † | K153521 | IH Implant System | 2016 |
| † | K120847 | ET/SS Implant System | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 32 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 98 ancestors have a recall of any class.
- 6 other devices also cite its predicate K153639.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210039: CORE1 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/K210039
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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