510(k) · Cleared
ClearedOne Plus Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseofuse, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 19, 2014 as substantially equivalent to K083067 (Osstem Implant Co., Ltd., 2009) and 5 other predicates after a 357-day review. Its family tree reaches back 12 generations to 1996. 1 later device descends from it.
- Decided
- Sep 19, 2014
- Review
- 357 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K960026 (1996). 62 ancestors in all, the oldest K894595 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- 2 generations backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- 1 generation backK083067 MS SystemOsstem Implant Co., Ltd. · 2009
- This deviceK133050 One Plus Implant SystemOsseofuse, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK151970 KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 3 generations backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- 2 generations backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- 1 generation backK083067 MS SystemOsstem Implant Co., Ltd. · 2009
- This deviceK133050 One Plus Implant SystemOsseofuse, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K151970KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −3 | K072959 | MS System (Denture) | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K080594 | MS System (Narrow Ridge) | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K083067 | MS System | Osstem Implant Co., Ltd. | 2009 | — |
| 0 (this device) | K133050 | One Plus Implant System | Osseofuse, Inc. | 2014 | — |
| +1 | K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K083067 | MS SystemSummary page 4…Dental Implant System ▪ Product Code: DZE ▪ Classification regulation: 21CFR872.3640 4. Predicate Device: ▪ MS System by OSSTEM IMPLANT CO., LTD (K083067) ▪ S-MINI IMPLANT SYSTEM by NEOBIOTECH CO., LTD (K112540) ▪ OSSEOFUSE DENTAL IMPLANT SYSTEM by Dynamic Innovations In… | 2009 |
| * | K112540 | S-Mini Implant SystemSummary page 4…fication regulation: 21CFR872.3640 4. Predicate Device: ▪ MS System by OSSTEM IMPLANT CO., LTD (K083067) ▪ S-MINI IMPLANT SYSTEM by NEOBIOTECH CO., LTD (K112540) ▪ OSSEOFUSE DENTAL IMPLANT SYSTEM by Dynamic Innovations Inc. (K110577) ▪ Spectra System (ScrewDirect Implant) by Im… | 2012 |
| * | K110577 | Osseofuse Dental Implant SystemSummary page 4…by OSSTEM IMPLANT CO., LTD (K083067) ▪ S-MINI IMPLANT SYSTEM by NEOBIOTECH CO., LTD (K112540) ▪ OSSEOFUSE DENTAL IMPLANT SYSTEM by Dynamic Innovations Inc. (K110577) ▪ Spectra System (ScrewDirect Implant) by Implant Direct LLC (K061319) ▪ Replace One Piece Implant by NOBEL BIOCARE… | 2011 |
| * | K061319 | Spectra SystemSummary page 4…TECH CO., LTD (K112540) ▪ OSSEOFUSE DENTAL IMPLANT SYSTEM by Dynamic Innovations Inc. (K110577) ▪ Spectra System (ScrewDirect Implant) by Implant Direct LLC (K061319) ▪ Replace One Piece Implant by NOBEL BIOCARE UAS INC. (K023952) ▪ Lifecore PrimaSolo One-Piece Implant System by Lif… | 2006 |
| * | K023952 | Replace One Piece Implant, HA, Replace One Piece Implant, TiuniteSummary page 4…amic Innovations Inc. (K110577) ▪ Spectra System (ScrewDirect Implant) by Implant Direct LLC (K061319) ▪ Replace One Piece Implant by NOBEL BIOCARE UAS INC. (K023952) ▪ Lifecore PrimaSolo One-Piece Implant System by Lifecore Biomedical, Inc.(K050506)… | 2003 |
| * | K050506 | Primasolo One-Piece Implants & Healing CapsSummary page 4…rect LLC (K061319) ▪ Replace One Piece Implant by NOBEL BIOCARE UAS INC. (K023952) ▪ Lifecore PrimaSolo One-Piece Implant System by Lifecore Biomedical, Inc.(K050506) Page 1 5. Description: The One Plus Implant System is a dental i… | 2005 |
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 |
|---|---|---|---|
| K151970 | KJ Mini Implant System | 2016 | 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 18 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 12 of the 62 ancestors have a recall of any class.
- Of its descendants, K151970 (Kj Meditech Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K083067.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 One Plus Implant System is intended to use in the treatment of missing teeth to support
prosthetic device, such as artificial teeth, in order to restore mastication in partially
edentulous patients. 3.0mm diameter implants are intended to be used in central or lateral
mandibular incisors. The One Plus Implant System is intended for single use only. It is for
delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133050 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133050: One Plus Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133050
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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