510(k) · Cleared
Recalled · Class II · 2026Straumann Bone Level Tapered Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Aug 20, 2014 as substantially equivalent to K062129 (Institut Straumann AG, 2006) and 9 other predicates after a 135-day review. Its family tree reaches back 12 generations to 1990. 105 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 20, 2014
- Review
- 135 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 2
- Predicates
- 10
Its longest line of descent runs back 12 generations to K894595 (1990). 88 ancestors in all, the oldest K894844 (1990). 105 later devices descend from it, 9 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- This deviceK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014
- Descendant · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 2 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 2 generations on · 20 of its ownK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 9 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 8 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 6 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 5 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 4 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 3 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 2 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 1 generation backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- This deviceK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014
Showing 5 of 105 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 105 · See all- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · cites it directly51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 2 generations on22descendants
- K212628DESS Dental Smart SolutionsTerrats Medical SL · 2022 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −9 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −8 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −6 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −5 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −4 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −3 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −2 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −1 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| 0 (this device) | K140878 | Straumann Bone Level Tapered Implant | Straumann USA, LLC | 2014 | — |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +2 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +2 | K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 14 | 0 |
| 2024 | 16 | 0 |
| 2025 | 23 | 0 |
| 2026 | 12 | 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? (10)
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 |
|---|---|---|---|
| * | K062129 | P.0004 ImplantsSummary page 5…e: Straumann® Bone Level Tapered Implants Predicate Device(s): • Straumann P.004 Implants – Ti Bone Level implants (K062129) • Straumann Dental Implant System – 3.3mm NC TiZr Bone Level… | 2006 |
| * | K083550 | Straumann Dental Implant SystemSummary page 5…(K062129) • Straumann Dental Implant System – 3.3mm NC TiZr Bone Level implants (K083550) • Straumann Dental Implant System – 4.1& 4.8mm TiZr Bone Lev… | 2009 |
| * | K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMSummary page 5…Level implants (K083550) • Straumann Dental Implant System – 4.1& 4.8mm TiZr Bone Level implants (K121131) • Straumann Dental Implant System (K123784) • Straumann Dental… | 2012 |
| * | K123784 | Straumann Dental Implant SystemSummary page 5…tal Implant System – 4.1& 4.8mm TiZr Bone Level implants (K121131) • Straumann Dental Implant System (K123784) • Straumann Dental Implant System (K130222) • Straumann Tissue… | 2013 |
| * | K130222 | Straumann Dental Implant SystemSummary page 5…Level implants (K121131) • Straumann Dental Implant System (K123784) • Straumann Dental Implant System (K130222) • Straumann Tissue Level Titanium Implants (K983742) • Strauma… | 2013 |
| * | K983742 | Iti Dental Implant SystemSummary page 5…ystem (K123784) • Straumann Dental Implant System (K130222) • Straumann Tissue Level Titanium Implants (K983742) • Straumann NC Anatomic Abutment (K071357) • Straumann NC Care… | 1999 |
| * | K071357 | P.004 NC Anatomic AbutmentsSummary page 5…System (K130222) • Straumann Tissue Level Titanium Implants (K983742) • Straumann NC Anatomic Abutment (K071357) • Straumann NC Cares Abutments (K081005) • Nobel Biocare, Nobe… | 2007 |
| * | K081005 | P.004 NC Cares Titanium and Ceramic AbutmentsSummary page 5…Titanium Implants (K983742) • Straumann NC Anatomic Abutment (K071357) • Straumann NC Cares Abutments (K081005) • Nobel Biocare, NobelSpeedy (K050406) • Nobel Biocare, NobelA… | 2008 |
| * | K050406 | Nobelspeedy ImplantsSummary page 5…n NC Anatomic Abutment (K071357) • Straumann NC Cares Abutments (K081005) • Nobel Biocare, NobelSpeedy (K050406) • Nobel Biocare, NobelActive (K071370) Device Description: The subject devices repre… | 2005 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 5…umann NC Cares Abutments (K081005) • Nobel Biocare, NobelSpeedy (K050406) • Nobel Biocare, NobelActive (K071370) Device Description: The subject devices represent a line extension of the previously cl… | 2007 |
| † | K081419 | Straumann Dental Implant System | 2009 |
| † | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | 2011 |
| † | K122855 | TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants | 2012 |
What descends from it? (105)
See all 1059 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170588 | DESS Dental Smart Solutions | 2017 | 86 |
| K173908 | DESS Dental Smart Solutions | 2018 | 51 |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | 2015 | 6 |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC… | 2017 | 5 |
| K160850 | Nucleoss Tpure Implant System | 2017 | 2 |
| K212538 | DESS Dental Implants | 2021 | 1 |
| K170287 | Dental Implants OKTAGON Bone Level Tapered Design | 2017 | 1 |
| K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech… | 2024 | 0 |
| K153758 | Straumann Bone Level Tapered Implants | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2026 | Class II | Z-2935-2026 | Under Investigation by firm | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest. |
| Sep 19, 2014 | Class II | Z-0117-2015 | Packaging process control | Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 88 ancestors have a recall of any class.
- Of its descendants, K170588 (Terrats Medical SL, 2017) has gone furthest, with 86 descendants of its own.
- 30 other devices also cite its predicate K062129.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is…
Read the full statement (217 words)
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140878: Straumann Bone Level Tapered Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140878
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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