510(k) · Cleared
Recalled · Class II · 2014BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · DZE Implant, Endosseous, Root-Form
Cleared on Jun 6, 2012 as substantially equivalent to K083550 (Straumann USA, 2009) and 1 other predicate after a 54-day review. Its family tree reaches back 9 generations to 1990. 124 later devices descend from it. It has been recalled once.
- Decided
- Jun 6, 2012
- Review
- 54 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K894595 (1990). 41 ancestors in all, the oldest K894844 (1990). 124 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 2 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 1 generation backK083550 Straumann Dental Implant SystemStraumann USA · 2009
- This deviceK121131 BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA · 2012
- Descendant · cites it directly · 122 of its ownK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- Descendant · cites it directly · 118 of its ownK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- Descendant · cites it directly · 105 of its ownK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
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 backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 2 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 1 generation backK083550 Straumann Dental Implant SystemStraumann USA · 2009
- This deviceK121131 BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA · 2012
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K123784Straumann Dental Implant SystemStraumann USA, LLC · 2013 · cites it directly122descendants
- K130222Straumann Dental Implant SystemStraumann USA, LLC · 2013 · cites it directly118descendants
- K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · cites it directly105descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 2 generations on51descendants
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 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −6 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −3 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −2 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −1 | K083550 | Straumann Dental Implant System | Straumann USA | 2009 | — |
| 0 (this device) | K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM | Straumann USA | 2012 | — |
| +1 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| +1 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| +1 | K140878 | Straumann Bone Level Tapered Implant | Straumann USA, LLC | 2014 | 2 |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 12 | 0 |
| 2023 | 17 | 0 |
| 2024 | 17 | 0 |
| 2025 | 24 | 0 |
| 2026 | 13 | 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? (2)
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 |
|---|---|---|---|
| * | K083550 | Straumann Dental Implant SystemSummary page 1…, Endosseous, Root-form Regulation Number: §872.3640 1. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K083550, Straumnann Dental Implant System K0621 29, Straumann P.004 Dental Implants 5. Description of the Device The… | 2009 |
| * | K062129 | P.0004 ImplantsSummary page 1…§872.3640 1. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) K083550, Straumnann Dental Implant System K0621 29, Straumann P.004 Dental Implants 5. Description of the Device The proposed Straumann Bone Level (BL) 04.1 mm and 04.… | 2006 |
What descends from it? (124)
See all 1244 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2014 | Class II | Z-0174-2015 | Packaging process control | Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 41 ancestors have a recall of any class.
- Of its descendants, K123784 (Straumann USA, LLC, 2013) has gone furthest, with 122 descendants of its own.
- 8 other devices also cite its predicate K083550.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). 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…
Read the full statement (144 words)
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). 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). When placing implants in the posterior region, we recommend using only large diameter implants.. 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/K121131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121131: BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121131
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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