510(k) · Cleared
Recalled · Class II · 2016Straumann® Dental Implant System ¿ Roxolid® SLA Implants
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 Jul 24, 2015 as substantially equivalent to K983742 (Institut Straumann AG, 1999) and 5 other predicates after a 108-day review. Its family tree reaches back 13 generations to 1990. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 24, 2015
- Review
- 108 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 13 generations to K894595 (1990). 89 ancestors in all, the oldest K894844 (1990). 6 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 deviceK150938 Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC · 2015
- Descendant · cites it directly · 4 of its ownK230108 Straumann® BLC and TLC ImplantsInstitut Straumann AG · 2023
- Descendant · 2 generations on · 2 of its ownK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK260061 BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK243521 Conical Ti Base abutmentsBioHorizons Implant Systems, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK234049 Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG · 2024
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 deviceK150938 Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG · 2023 · cites it directly4descendants
- K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024 · 2 generations on2descendants
- K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc. · 2026 · 3 generations on0descendants
- K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc. · 2025 · 3 generations on0descendants
- K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG · 2024 · 2 generations on0descendants
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) | K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | Straumann USA, LLC | 2015 | — |
| +1 | K230108 | Straumann® BLC and TLC Implants | Institut Straumann AG | 2023 | — |
| +2 | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024 | — |
| +3 | K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026 | — |
| +3 | K243521 | Conical Ti Base abutments | BioHorizons Implant Systems, Inc. | 2025 | — |
| +2 | K234049 | Straumann® BLC and TLC Implants - Line extension | Institut Straumann AG | 2024 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K983742 | Iti Dental Implant SystemSummary page 4…predicates listed below is a primary predicate for a portion of the subject devices of this submission. K983742 – All in One Two Part Implant (Straumann) K012757 – Tapered Implant Modification (Straumann)… | 1999 |
| * | K012757 | Iti Dental Implant SystemSummary page 4…the subject devices of this submission. K983742 – All in One Two Part Implant (Straumann) K012757 – Tapered Implant Modification (Straumann) K033922 – Standard Plus Implant (Straumann)… | 2001 |
| * | K033922 | Modification to Iti Dental Implant SystemSummary page 4…K983742 – All in One Two Part Implant (Straumann) K012757 – Tapered Implant Modification (Straumann) K033922 – Standard Plus Implant (Straumann) K062129 – Bone Level Implants (Straumann)… | 2004 |
| * | K062129 | P.0004 ImplantsSummary page 4…K012757 – Tapered Implant Modification (Straumann) K033922 – Standard Plus Implant (Straumann) K062129 – Bone Level Implants (Straumann) K111357 – NNC Roxolid Implant System… | 2006 |
| * | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemSummary page 4…K033922 – Standard Plus Implant (Straumann) K062129 – Bone Level Implants (Straumann) K111357 – NNC Roxolid Implant System K140878 – Bone Level Tapered Implants Reference Device(s) K… | 2011 |
| * | K140878 | Straumann Bone Level Tapered ImplantSummary page 4…K062129 – Bone Level Implants (Straumann) K111357 – NNC Roxolid Implant System K140878 – Bone Level Tapered Implants Reference Device(s) K033984 – SLActive Surface Finish K081… | 2014 |
| † | K033984 | Straumann Dental Implant System | 2004 |
| † | K081419 | Straumann Dental Implant System | 2009 |
| † | K083550 | Straumann Dental Implant System | 2009 |
| † | K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM | 2012 |
| † | K122855 | TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental Implants | 2012 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2016 | Class II | Z-2535-2016 | Under Investigation by firm | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration |
| Jul 14, 2016 | Class II | Z-2534-2016 | Under Investigation by firm | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 89 ancestors have a recall of any class.
- Of its descendants, K230108 (Institut Straumann AG, 2023) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K983742.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 (100 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).
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/K150938 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150938: Straumann® Dental Implant System ¿ Roxolid® SLA Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150938
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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