510(k) · Cleared
ClearedMagicore II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innobiosurg Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 28, 2020 as substantially equivalent to K152520 (Innobiosurg Co., Ltd., 2016) after a 259-day review. Its family tree reaches back 9 generations to 1990. 3 later devices descend from it.
- Decided
- Apr 28, 2020
- Review
- 259 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 20 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK152520 Magicore SystemInnobiosurg Co., Ltd. · 2016
- This deviceK192197 Magicore II SystemInnobiosurg Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK201621 Magicore II SystemInnobiosurg Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK212517 Magicore SystemInnobiosurg Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK220517 IBS SystemInnobiosurg Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 5 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 4 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 3 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 2 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 1 generation backK152520 Magicore SystemInnobiosurg Co., Ltd. · 2016
- This deviceK192197 Magicore II SystemInnobiosurg Co., Ltd. · 2020
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 |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −5 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −4 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −3 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −2 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K152520 | Magicore System | Innobiosurg Co., Ltd. | 2016 | — |
| 0 (this device) | K192197 | Magicore II System | Innobiosurg Co., Ltd. | 2020 | — |
| +1 | K201621 | Magicore II System | Innobiosurg Co., Ltd. | 2020 | — |
| +1 | K212517 | Magicore System | Innobiosurg Co., Ltd. | 2021 | — |
| +2 | K220517 | IBS System | Innobiosurg Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K152520 | Magicore SystemSummary page 4…Class II • Date prepared: April 26, 2020 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate K152520, Magicore System manufactured by InnoBioSurg Co., Ltd. Reference Device K072570, Nobelactive Multi Unit Abutment by Nobel Biocar… | 2016 |
| † | K072570 | Nobelactive Multi Unit Abutment | 2007 |
| † | K080594 | MS System (Narrow Ridge) | 2008 |
| † | K150344 | Dentis Dental Implant System | 2015 |
| † | K153350 | IBS Implant System | 2016 |
| † | K160670 | ET US SS Prosthetic system | 2017 |
| † | K161689 | OSSTEM Implant System - Abutment | 2017 |
| † | K162099 | IBS Implant System II | 2017 |
| † | K171027 | Dentis Dental Implant System | 2017 |
| † | K173120 | CCM Abutment System | 2018 |
| † | K173575 | OsteoReady Dental Implant System | 2018 |
| † | K140806 | Ibs Implant System | 2015 |
What descends from it? (3)
2 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?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K201621 (Innobiosurg Co., Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K152520.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Magicore Il System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
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/K192197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192197: Magicore II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192197
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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