510(k) · Cleared
ClearedEM SA Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hiossen, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Nov 15, 2019 as substantially equivalent to K122171 (Osstem Implant Co., Ltd., 2012) after a 193-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.
- Decided
- Nov 15, 2019
- Review
- 193 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K960026 (1996). 45 ancestors in all, the oldest K894595 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations between
- 3 generations backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- 2 generations backK083067 MS SystemOsstem Implant Co., Ltd. · 2009
- 1 generation backK122171 MS SA Implant SystemOsstem Implant Co., Ltd. · 2012
- This deviceK191201 EM SA Implant SystemHiossen, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK242379 LL Implant SystemOssvis Co., Ltd. · 2024
Show all 13 generations
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 11 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 10 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 6 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 5 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 4 generations backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- 3 generations backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- 2 generations backK083067 MS SystemOsstem Implant Co., Ltd. · 2009
- 1 generation backK122171 MS SA Implant SystemOsstem Implant Co., Ltd. · 2012
- This deviceK191201 EM SA Implant SystemHiossen, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K242379LL Implant SystemOssvis Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −12 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −6 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −5 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −4 | K072959 | MS System (Denture) | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K080594 | MS System (Narrow Ridge) | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K083067 | MS System | Osstem Implant Co., Ltd. | 2009 | — |
| −1 | K122171 | MS SA Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| 0 (this device) | K191201 | EM SA Implant System | Hiossen, Inc. | 2019 | — |
| +1 | K242379 | LL Implant System | Ossvis Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242379 | LL Implant System | 2024 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 6 of the 45 ancestors have a recall of any class.
- Of its descendants, K242379 (Ossvis Co., Ltd., 2024) 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?
The EM SA Implant System (DENTURE) is intended to be place in the bone of the upper or lower jaw arches providing support to dental prosthetic devices, specifically for denture stabilization to restore a patient's chewing function. It is intended for single use only.
The EM SA Implant (NARROW RIDGE) is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191201: EM SA 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/K191201
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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