510(k) · Cleared
ClearedKJ Mini Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kj Meditech Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 21, 2016 as substantially equivalent to K133050 (Osseofuse, Inc., 2014) and 5 other predicates after a 463-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Oct 21, 2016
- Review
- 463 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K960026 (1996). 120 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- 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 backK133050 One Plus Implant SystemOsseofuse, Inc. · 2014
- This deviceK151970 KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016
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 backK133050 One Plus Implant SystemOsseofuse, Inc. · 2014
- This deviceK151970 KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016
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 | K133050 | One Plus Implant System | Osseofuse, Inc. | 2014 | — |
| 0 (this device) | K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 10 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 7 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K133050 | One Plus Implant SystemSummary page 4…ZE, NHA • Classification regulation: 21CFR872.3640 4. Predicate Device: • Primary Predicate Device: One Plus Implant System by OsseoFuse Co., Ltd. (K133050) • Reference Predicate Device: MS System by OSSTEM Implant Co., Ltd. (K083067) 510(k) Submission.… | 2014 |
| * | K083067 | MS SystemSummary page 4…ary Predicate Device: One Plus Implant System by OsseoFuse Co., Ltd. (K133050) • Reference Predicate Device: MS System by OSSTEM Implant Co., Ltd. (K083067) 510(k) Submission. 510(k) summary , 1 / 10 page Spectra Syste… | 2009 |
| * | K061319 | Spectra SystemSummary page 5…, Ltd. (K083067) 510(k) Submission. 510(k) summary , 1 / 10 page Spectra System by Implant Direct LLC (K061319) Intra-Lock Dental Implant System with Blossom by Intra-Lock International Inc. (K103194) MILO Dental Imp… | 2006 |
| * | K103194 | Intra-Lock Dental Implants with BlossomSummary page 5…ge Spectra System by Implant Direct LLC (K061319) Intra-Lock Dental Implant System with Blossom by Intra-Lock International Inc. (K103194) MILO Dental Implant System by Intra-Lock International Inc. (K050970) MS System(Denture) by OSSTEM Implant Co.,… | 2011 |
| * | K050970 | Milo Dental Implant SystemSummary page 5…Intra-Lock Dental Implant System with Blossom by Intra-Lock International Inc. (K103194) MILO Dental Implant System by Intra-Lock International Inc. (K050970) MS System(Denture) by OSSTEM Implant Co., Ltd. (K072959) 5. Device Description: KJ Mini Implant System is a dental… | 2005 |
| * | K072959 | MS System (Denture)Summary page 5…nternational Inc. (K103194) MILO Dental Implant System by Intra-Lock International Inc. (K050970) MS System(Denture) by OSSTEM Implant Co., Ltd. (K072959) 5. Device Description: KJ Mini Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy inten… | 2008 |
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 20 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 18 of the 120 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 KJ Mini 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. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini 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/K151970 · printed Nov 4, 2026
Cite this page
510(k) Report. “K151970: KJ Mini Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K151970
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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