510(k) · Cleared
ClearedMS 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 Feb 2, 2009 as substantially equivalent to K072959 (Osstem Implant Co., Ltd., 2008) and 1 other predicate after a 110-day review. Its family tree reaches back 11 generations to 1996. 7 later devices descend from it.
- Decided
- Feb 2, 2009
- Review
- 110 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K960026 (1996). 24 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- 1 generation backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- This deviceK083067 MS SystemOsstem Implant Co., Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK122171 MS SA Implant SystemOsstem Implant Co., Ltd. · 2012
- Descendant · 2 generations on · 1 of its ownK191201 EM SA Implant SystemHiossen, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK133050 One Plus Implant SystemOsseofuse, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK241127 INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK242379 LL Implant SystemOssvis Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- 1 generation backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- This deviceK083067 MS SystemOsstem Implant Co., Ltd. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122171MS SA Implant SystemOsstem Implant Co., Ltd. · 2012 · cites it directly2descendants
- K191201EM SA Implant SystemHiossen, Inc. · 2019 · 2 generations on1descendant
- K133050One Plus Implant SystemOsseofuse, Inc. · 2014 · cites it directly1descendant
- K241127INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024 · cites it directly0descendants
- K242379LL Implant SystemOssvis Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −2 | K072959 | MS System (Denture) | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K080594 | MS System (Narrow Ridge) | Osstem Implant Co., Ltd. | 2008 | — |
| 0 (this device) | K083067 | MS System | Osstem Implant Co., Ltd. | 2009 | — |
| +1 | K122171 | MS SA Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| +2 | K191201 | EM SA Implant System | Hiossen, Inc. | 2019 | — |
| +1 | K133050 | One Plus Implant System | Osseofuse, Inc. | 2014 | — |
| +1 | K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024 | — |
| +3 | K242379 | LL Implant System | Ossvis Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K072959 | MS System (Denture)Summary page 1…Class 1l DZE 3. Predicate Device: MS System (Denture), OSSTEM Implant Co., Ltd. (K072959) MS System (Narrow Ridge), OSSTEM Implant Co., Ltd. (K080594) 4. Description: The MS System is a dental implant made of Ti… | 2008 |
| * | K080594 | MS System (Narrow Ridge)Summary page 1…DZE 3. Predicate Device: MS System (Denture), OSSTEM Implant Co., Ltd. (K072959) MS System (Narrow Ridge), OSSTEM Implant Co., Ltd. (K080594) 4. Description: The MS System is a dental implant made of Ti-6A1-4V metal. The MS System is similar to other commercially… | 2008 |
| † | K080129 | Secure Implant System (2.5/3.0MM) | 2008 |
What descends from it? (7)
5 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 13 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K122171 (Osstem Implant Co., Ltd., 2012) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K072959.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 MS System (Denture) is intended to be place in the bone of the upper or lower jaw arches to provide support the prosthetic devices to restore the patient's chewing function, including the denture stabilization. MS System (Denture) is intended for single use only.
The MS System (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. MS System (Narrow Ridge) is intended for single use only. It is not for immediate loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083067: MS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083067
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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