510(k) · Cleared
ClearedIS-III active System_S-narrow Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neobiotech Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 14, 2019 as substantially equivalent to K130462 (Paltop Advanced Dental Solutions, Ltd., 2013) and 1 other predicate after a 135-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.
- Decided
- Aug 14, 2019
- Review
- 135 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K960026 (1996). 109 ancestors in all, the oldest K874590 (1988). 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 backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- 2 generations backK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · Recalled
- 1 generation backK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · Recalled
- This deviceK190849 IS-III active System_S-narrow TypeNeobiotech Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK240091 NB Mini Implant SystemArum Dentistry 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 backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 3 generations backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- 2 generations backK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · Recalled
- 1 generation backK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · Recalled
- This deviceK190849 IS-III active System_S-narrow TypeNeobiotech Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K240091NB Mini Implant SystemArum Dentistry 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 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −3 | K071803 | Ards Dental Implants | Ards, Ltd. | 2008 | — |
| −2 | K112795 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2012 | 5 |
| −1 | K130462 | Paltop Narrow Implant, Paltop Short Implant | Paltop Advanced Dental Solutions, Ltd. | 2013 | 1 |
| 0 (this device) | K190849 | IS-III active System_S-narrow Type | Neobiotech Co., Ltd. | 2019 | — |
| +1 | K240091 | NB Mini Implant System | Arum Dentistry Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 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? (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 |
|---|---|---|---|
| * | K130462 | Paltop Narrow Implant, Paltop Short ImplantSummary page 4…Class II • Date Prepared: 08/13/2019 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K130462, Paltop Narrow Implant manufactured by Paltop Advanced Dental Solutions Ltd. Reference Devices • K150537, MiNi Internal Impla… | 2013 |
| * | K181138 | IS-III active SystemSummary page 4…L Narrow Implant System by Dentis Co., Ltd. • K171728, MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1 x 18mm and 2.4x18mm by Sterngold Dental, LLC. • K181138, IS-III active System by Neobiotech Co., Ltd. • K181178, S-mini active Fixture by Neobiotech Co., Ltd. Indications for Use:… | 2018 |
| † | K150537 | MiNi Internal Implant System | 2015 |
| † | K161244 | s-Clean OneQ-SL Narrow Implant System | 2016 |
| † | K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | 2017 |
| † | K181178 | S-mini active Fixture | 2018 |
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 |
|---|---|---|---|
| K240091 | NB Mini 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 5 companies; a new generation was cleared every 10 months on median.
- 13 of the 109 ancestors have a recall of any class.
- Of its descendants, K240091 (Arum Dentistry Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130462.
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 IS-III active System_S-narrow Type is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient’s chewing function.
The IS-III active System_S-narrow Type is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190849 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190849: IS-III active System_S-narrow Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190849
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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