510(k) · Cleared
ClearedNT/IT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 15, 2008 as substantially equivalent to K072570 (Nobel Biocare AB, 2007) and 5 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Jul 15, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K894595 (1990). 51 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- This deviceK081078 NT/IT SystemOsstem Implant Co., Ltd. · 2008
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 1 generation backK072570 Nobelactive Multi Unit AbutmentNobel Biocare AB · 2007 · Recalled
- This deviceK081078 NT/IT SystemOsstem Implant Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −1 | K072570 | Nobelactive Multi Unit Abutment | Nobel Biocare AB | 2007 | 1 |
| 0 (this device) | K081078 | NT/IT System | Osstem Implant Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 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 |
|---|---|---|---|
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 1…Class II DZE 3. Predicate Device: The NobelEsthetics, NobelBiocare USA LLC, K072570 The SynOcta Prosthetic System, STRAUMANN USA LLC, K073628 The Solid Abutment Prosthetic System, STRAUMANN USA LLC, K080286… | 2007 |
| * | K073628 | Synocta AbutmentsSummary page 1…DZE 3. Predicate Device: The NobelEsthetics, NobelBiocare USA LLC, K072570 The SynOcta Prosthetic System, STRAUMANN USA LLC, K073628 The Solid Abutment Prosthetic System, STRAUMANN USA LLC, K080286 The SS System, Osstem Implant Co., Ltd, K062051 The GS… | 2008 |
| * | K080286 | Cementable Abuntments; Temporary Copings; Protective CapsSummary page 1…he NobelEsthetics, NobelBiocare USA LLC, K072570 The SynOcta Prosthetic System, STRAUMANN USA LLC, K073628 The Solid Abutment Prosthetic System, STRAUMANN USA LLC, K080286 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Oss… | 2008 |
| * | K062051 | SS SystemSummary page 1…The SynOcta Prosthetic System, STRAUMANN USA LLC, K073628 The Solid Abutment Prosthetic System, STRAUMANN USA LLC, K080286 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Osstem Implant Co., Ltd, K073247 4. Description: T… | 2006 |
| * | K063861 | GS SystemSummary page 1…K073628 The Solid Abutment Prosthetic System, STRAUMANN USA LLC, K080286 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Osstem Implant Co., Ltd, K073247 4. Description: The NT/IT System is a dental implant made of titaniu… | 2007 |
| * | K073247 | US/SS/GS SystemSummary page 1…N USA LLC, K080286 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Osstem Implant Co., Ltd, K073247 4. Description: The NT/IT System is a dental implant made of titanium metal intended to be surgically placed in the bone o… | 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 18 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 51 ancestors have a recall of any class.
- 17 other devices also cite its predicate K072570.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 NT/IT 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. The NT/IT System is for single and two stage surgical procedures. It is not for immediate load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081078: NT/IT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081078
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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