510(k) · Cleared
ClearedGS Fixture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 6, 2007 as substantially equivalent to K063861 (Osstem Implant Co., Ltd., 2007) after a 26-day review. Its family tree reaches back 7 generations to 1990. 15 later devices descend from it.
- Decided
- Nov 6, 2007
- Review
- 26 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894595 (1990). 17 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 4 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 3 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 2 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 1 generation backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- This deviceK072896 GS Fixture SystemOsstem Implant Co., Ltd. · 2007
- Descendant · cites it directly · 14 of its ownK121047 Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd. · 2012
- Descendant · 2 generations on · 5 of its ownK131682 UD Implant SystemMedimecca Co., Ltd. · 2013
- Descendant · 3 generations on · 3 of its ownK160536 Chaorum Implant SystemMedimecca Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK150060 J2A Dental Implant System, J2C Dental Implant SystemKj Meditech Co., Ltd. · 2015
- Descendant · 3 generations on · 1 of its ownK161923 J2A SLA Dental Implant SystemKj Meditech Co., Ltd. · 2017
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K121047Hero II Dental Implant System, IS Dental Implant SystemKj Meditech Co., Ltd. · 2012 · cites it directly14descendants
- K131682UD Implant SystemMedimecca Co., Ltd. · 2013 · 2 generations on5descendants
- K160536Chaorum Implant SystemMedimecca Co., Ltd. · 2017 · 3 generations on3descendants
- K150060J2A Dental Implant System, J2C Dental Implant SystemKj Meditech Co., Ltd. · 2015 · 2 generations on2descendants
- K161923J2A SLA Dental Implant SystemKj Meditech Co., Ltd. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −4 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −3 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −2 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −1 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| 0 (this device) | K072896 | GS Fixture System | Osstem Implant Co., Ltd. | 2007 | — |
| +1 | K121047 | Hero II Dental Implant System, IS Dental Implant System | Kj Meditech Co., Ltd. | 2012 | — |
| +2 | K131682 | UD Implant System | Medimecca Co., Ltd. | 2013 | — |
| +3 | K160536 | Chaorum Implant System | Medimecca Co., Ltd. | 2017 | — |
| +2 | K150060 | J2A Dental Implant System, J2C Dental Implant System | Kj Meditech Co., Ltd. | 2015 | — |
| +3 | K161923 | J2A SLA Dental Implant System | Kj Meditech Co., Ltd. | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K063861 | GS SystemSummary page 1…Class II DZE 3. Predicate Device: GS System, Osstem Implant Co., Ltd, (K063861) 4. Description: The GS Fixture System is a dental implant made of titanium metal intended to be surgically placed in the… | 2007 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121047 | Hero II Dental Implant System, IS Dental Implant System | 2012 | 14 |
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 17 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K121047 (Kj Meditech Co., Ltd., 2012) has gone furthest, with 14 descendants of its own.
- 9 other devices also cite its predicate K063861.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
GS fixture 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. GS fixture System is for single and two stage surgical procedures. It is not for immediate load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072896 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072896: GS Fixture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072896
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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