510(k) · Cleared
ClearedStella
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shinhung Mst Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 4, 2023 as substantially equivalent to K120847 (Osstem Implant Co., Ltd., 2012) and 2 other predicates after a 353-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Jun 4, 2023
- Review
- 353 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K894595 (1990). 50 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- This deviceK221752 StellaShinhung Mst Co., Ltd. · 2023
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 8 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 7 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 6 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 5 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- This deviceK221752 StellaShinhung Mst Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −8 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −7 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −6 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −5 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −2 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −1 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| 0 (this device) | K221752 | Stella | Shinhung Mst Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K120847 | ET/SS Implant SystemSummary page 4…seous Dental Implant • Product Code: DZE, NHA • Classification regulation: 21CFR 872.3640 4. Predicate Device: SSII/III SA Fixture by OSSTEM Implant Co., Ltd. (K120847) Luna Dental Implant System by SHINHUNG MST CO., LTD. (K123155 / K160106) 5. Description: Stella is a dental implant fix… | 2012 |
| * | K123155 | Luna Dental Implant SystemSummary page 4…on regulation: 21CFR 872.3640 4. Predicate Device: SSII/III SA Fixture by OSSTEM Implant Co., Ltd. (K120847) Luna Dental Implant System by SHINHUNG MST CO., LTD. (K123155 / K160106) 5. Description: Stella is a dental implant fixture that is implanted in the jawbone to support and maintain p… | 2013 |
| * | K160106 | Luna Dental Implant SystemSummary page 4…ion: 21CFR 872.3640 4. Predicate Device: SSII/III SA Fixture by OSSTEM Implant Co., Ltd. (K120847) Luna Dental Implant System by SHINHUNG MST CO., LTD. (K123155 / K160106) 5. Description: Stella is a dental implant fixture that is implanted in the jawbone to support and maintain prosthetic… | 2016 |
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 33 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 50 ancestors have a recall of any class.
- 10 other devices also cite its predicate K120847.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient’s chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.
The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.
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/K221752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221752: Stella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221752
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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