510(k) · Cleared
ClearedIS-III active System
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 Oct 3, 2018 as substantially equivalent to K113554 (Neobiotech Co., Ltd., 2012) after a 156-day review. Its family tree reaches back 10 generations to 1990. 23 later devices descend from it.
- Decided
- Oct 3, 2018
- Review
- 156 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894595 (1990). 26 ancestors in all. 23 later devices descend from it, 11 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 1 generation backK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- This deviceK181138 IS-III active SystemNeobiotech Co., Ltd. · 2018
- Descendant · cites it directly · 8 of its ownK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · cites it directly · 5 of its ownK213506 NB 1 SA Implant SystemArum Dentistry Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · 2 generations on · 1 of its ownK231426 8plant Implant SystemHoowon Edi Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK231753 Oneday Implant AbutmentOneday Biotech Co., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 6 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 5 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 4 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 3 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 1 generation backK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- This deviceK181138 IS-III active SystemNeobiotech Co., Ltd. · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K211090ZENEX Implant SystemIzenimplant Co., Ltd. · 2022 · cites it directly8descendants
- K213506NB 1 SA Implant SystemArum Dentistry Co., Ltd. · 2022 · cites it directly5descendants
- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · cites it directly1descendant
- K2314268plant Implant SystemHoowon Edi Co., Ltd. · 2024 · 2 generations on1descendant
- K231753Oneday Implant AbutmentOneday Biotech Co., Ltd. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −6 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −5 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −4 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −3 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| −1 | K113554 | Cmi Implant IS System | Neobiotech Co., Ltd. | 2012 | — |
| 0 (this device) | K181138 | IS-III active System | Neobiotech Co., Ltd. | 2018 | — |
| +1 | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +1 | K213506 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022 | — |
| +1 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +2 | K231426 | 8plant Implant System | Hoowon Edi Co., Ltd. | 2024 | — |
| +2 | K231753 | Oneday Implant Abutment | Oneday Biotech Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K113554 | Cmi Implant IS SystemSummary page 4…: Class II • Date Prepared: 10/03/2018 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K113554, CMI Implant IS System manufactured by Neobiotech Co., Ltd. Reference Devices • K120503, CMI Implant IS II active manufacture… | 2012 |
| † | K120503 | Cmi Implant IS II Active | 2012 |
| † | K160828 | Dentium Implantium & SuperLine Prosthetics | 2016 |
| † | K173938 | IS-III HActive Fixture | 2018 |
| † | K070228 | Implantium Prosthetics | 2007 |
What descends from it? (23)
See all 2311 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211090 | ZENEX Implant System | 2022 | 8 |
| K213506 | NB 1 SA Implant System | 2022 | 5 |
| K252585 | ZENEX Implant System_R-System | 2026 | 1 |
| K231395 | INNO SLA Submerged Narrow Implant System | 2023 | 1 |
| K223924 | LW Implant System | 2023 | 1 |
| K210499 | Alpha Dent Implants Dental Implants System | 2021 | 1 |
| K190849 | IS-III active System_S-narrow Type | 2019 | 1 |
| K251605 | DIMPLO Implant System | 2025 | 0 |
| K220517 | IBS System | 2022 | 0 |
| K210354 | SNUCONE Bone Level Implant System | 2022 | 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 28 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K211090 (Izenimplant Co., Ltd., 2022) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K113554.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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-111 active System is indicated for use in partially or fully edentulous mandibles and maxillae. in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. IS-111 active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than Smm are indicated for molar regions.
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/K181138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181138: IS-III active System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181138
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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