510(k) · Cleared
ClearedNucleoss Tpure Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · DZE Implant, Endosseous, Root-Form
Cleared on Aug 4, 2017 as substantially equivalent to K140878 (Straumann USA, LLC, 2014) and 3 other predicates after a 494-day review. Its family tree reaches back 13 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 4, 2017
- Review
- 494 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K894595 (1990). 221 ancestors in all, the oldest K781060 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- This deviceK160850 Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017
- Descendant · cites it directly · 0 of its ownK231100 Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing…Proimtech Saglik Urunleri Anonim Sirketi · 2024
- Descendant · cites it directly · 0 of its ownK192062 Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST · 2020
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 10 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 9 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 8 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 7 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 6 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 5 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 4 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 3 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 2 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- This deviceK160850 Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017
Most influential descendants
Showing 2 of 2 · See all- K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi · 2024 · cites it directly0descendants
- K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −10 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −9 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −8 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −7 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −6 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −5 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −4 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −3 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −2 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −1 | K140878 | Straumann Bone Level Tapered Implant | Straumann USA, LLC | 2014 | 2 |
| 0 (this device) | K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017 | — |
| +1 | K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap… | Proimtech Saglik Urunleri Anonim Sirketi | 2024 | — |
| +1 | K192062 | Nucleoss T6 Dental Implant System | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 4 | 0 |
| 1992 | 4 | 0 |
| 1993 | 13 | 0 |
| 1994 | 12 | 0 |
| 1995 | 11 | 0 |
| 1996 | 16 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 9 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 14 | 0 |
| 2003 | 14 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 8 | 0 |
| 2007 | 12 | 0 |
| 2008 | 6 | 0 |
| 2009 | 9 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K140878 | Straumann Bone Level Tapered ImplantSummary page 4…atory Class: II Classification name: 21 CFR 872.3640 Endosseous Dental implant III. PREDICATE DEVICE Primary Predicate device: Straumann Bone Level Tapered Implants - K140878 Reference Predicate devices: Klockner Dental Implant Abutments (II) - K151194 Klockner Dental Implant Abutments - K122988 Zimmer… | 2014 |
| * | K151194 | Klockner Dental Implant Abutments (II)Summary page 4…III. PREDICATE DEVICE Primary Predicate device: Straumann Bone Level Tapered Implants - K140878 Reference Predicate devices: Klockner Dental Implant Abutments (II) - K151194 Klockner Dental Implant Abutments - K122988 Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System - K141544 Straumann… | 2016 |
| * | K122988 | Klockner Dental Implant AbutmentsSummary page 4…evice: Straumann Bone Level Tapered Implants - K140878 Reference Predicate devices: Klockner Dental Implant Abutments (II) - K151194 Klockner Dental Implant Abutments - K122988 Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System - K141544 Straumann Sterile Healing Solution - K161677 === Pag… | 2013 |
| * | K141544 | Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemSummary page 4…devices: Klockner Dental Implant Abutments (II) - K151194 Klockner Dental Implant Abutments - K122988 Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System - K141544 Straumann Sterile Healing Solution - K161677 IV. DEVICE DESCRIPTION The Nucleoss Tpure Implant System consists o… | 2014 |
| † | K161677 | Straumann Sterile Healing Solution | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 27 of the 221 ancestors have a recall of any class.
- Of its descendants, K231100 (Proimtech Saglik Urunleri Anonim Sirketi, 2024) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K140878.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Nucleoss Tpure Implant System are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function.
Nucleoss Tpure Dental Implants are intended for delayed loading after 12 weeks.
Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss Tpure Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdenture for edentulous or partially edentulous patients.
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/K160850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160850: Nucleoss Tpure 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/K160850
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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