510(k) · Cleared
ClearedMS System (Narrow Ridge)
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 Sep 3, 2008 as substantially equivalent to K071235 (Zimmer Dental, Inc., 2007) and 2 other predicates after a 184-day review. Its family tree reaches back 10 generations to 1996. 42 later devices descend from it.
- Decided
- Sep 3, 2008
- Review
- 184 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K960026 (1996). 23 ancestors in all. 42 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 6 generations between
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- This deviceK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- Descendant · cites it directly · 30 of its ownK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- Descendant · 2 generations on · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · 2 generations on · 7 of its ownK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
- Descendant · cites it directly · 7 of its ownK083067 MS SystemOsstem Implant Co., Ltd. · 2009
- Descendant · 2 generations on · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 8 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 7 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- This deviceK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K182091Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019 · cites it directly30descendants
- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · 2 generations on8descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · 2 generations on7descendants
- K083067MS SystemOsstem Implant Co., Ltd. · 2009 · cites it directly7descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −9 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −3 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −2 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −1 | K072959 | MS System (Denture) | Osstem Implant Co., Ltd. | 2008 | — |
| 0 (this device) | K080594 | MS System (Narrow Ridge) | Osstem Implant Co., Ltd. | 2008 | — |
| +1 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| +2 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +2 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +1 | K083067 | MS System | Osstem Implant Co., Ltd. | 2009 | — |
| +2 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 9 | 0 |
| 2024 | 10 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K071235 | Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13Summary page 1…Class II DZE 3. Predicate Device: Zimmer One-Piece Implants, Zimmer Dental Inc. (K071235). NobelDirect® 3.0, Nobel Biocare USA LLC. (K070857) MS System (Denture), OSSTEM Implant Co., Ltd. (K072959) 4. Descriptio… | 2007 |
| * | K070857 | Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MMSummary page 1…DZE 3. Predicate Device: Zimmer One-Piece Implants, Zimmer Dental Inc. (K071235). NobelDirect® 3.0, Nobel Biocare USA LLC. (K070857) MS System (Denture), OSSTEM Implant Co., Ltd. (K072959) 4. Description: The MS System (Narrow Ridge) is a dental implant… | 2007 |
| * | K072959 | MS System (Denture)Summary page 1…vice: Zimmer One-Piece Implants, Zimmer Dental Inc. (K071235). NobelDirect® 3.0, Nobel Biocare USA LLC. (K070857) MS System (Denture), OSSTEM Implant Co., Ltd. (K072959) 4. Description: The MS System (Narrow Ridge) is a dental implant made of Ti-6AI-4V metal. The MS System (Narrow Ridge) is… | 2008 |
What descends from it? (42)
See all 424 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 12 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K182091 (Osstem Implant Co., Ltd., 2019) has gone furthest, with 30 descendants of its own.
- 3 other devices also cite its predicate K071235.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 (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) are intended for single use only and not for immediate loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080594 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080594: MS System (Narrow Ridge).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080594
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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