510(k) · Cleared
ClearedIS-III HActive Fixture
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 May 24, 2018 as substantially equivalent to K120503 (Neobiotech Co., Ltd., 2012) and 3 other predicates after a 149-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- May 24, 2018
- Review
- 149 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K894595 (1990). 49 ancestors in all, the oldest K852765 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 2 generations backK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- 1 generation backK120503 Cmi Implant IS II ActiveNeobiotech Co., Ltd. · 2012
- This deviceK173938 IS-III HActive FixtureNeobiotech Co., Ltd. · 2018
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 7 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 6 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 5 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 4 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 2 generations backK113554 Cmi Implant IS SystemNeobiotech Co., Ltd. · 2012
- 1 generation backK120503 Cmi Implant IS II ActiveNeobiotech Co., Ltd. · 2012
- This deviceK173938 IS-III HActive FixtureNeobiotech Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −7 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −6 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −5 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −4 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| −2 | K113554 | Cmi Implant IS System | Neobiotech Co., Ltd. | 2012 | — |
| −1 | K120503 | Cmi Implant IS II Active | Neobiotech Co., Ltd. | 2012 | — |
| 0 (this device) | K173938 | IS-III HActive Fixture | Neobiotech Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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? (4)
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 |
|---|---|---|---|
| * | K120503 | Cmi Implant IS II ActiveSummary page 5…ver screws are fabricated from Ti-6Al-4V ELI of ASTM F136. Predicate Devices: The subject device is substantially equivalent to the following predicate devices: x K120503, CMI Implant IS II active manufactured by Neobiotech Co., Ltd. x K113554, CMI Implant IS System manufactured by Neobiotech Co… | 2012 |
| * | K113554 | Cmi Implant IS SystemSummary page 4…0/15.0mm. (Do not offer 3.5 x 7.3mm implant, 6.0 x 15mm implant, or 7.0 x 15mm implant) IS-III HActive Fixture is compatible with: K number List of Abutments K113554 Healing Abutment, Abutment(Cemented(Hex/non-Hex), Angled, SCRP), Solid Abutment, UCLA Gold Abutme… | 2012 |
| * | K073033 | Legacy Dental ImplantsSummary page 5…ate devices: x K120503, CMI Implant IS II active manufactured by Neobiotech Co., Ltd. x K113554, CMI Implant IS System manufactured by Neobiotech Co., Ltd. x K073033, Legacy System Dental Implant With HA Coating manufactured by Implant Direct LLC x K111364, Dentis HAPTITE Implant System, ma… | 2007 |
| * | K111364 | Haptite Coating Implant SystemSummary page 5…K113554, CMI Implant IS System manufactured by Neobiotech Co., Ltd. x K073033, Legacy System Dental Implant With HA Coating manufactured by Implant Direct LLC x K111364, Dentis HAPTITE Implant System, manufactured by Dentis Co.,Ltd. Comparison to Predicate Devices: 1) Fixture… | 2012 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 49 ancestors have a recall of any class.
- 1 other device also cites its predicate K120503.
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-III HActive Fixture is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. It is intended 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/K173938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173938: IS-III HActive Fixture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173938
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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