510(k) · Cleared
ClearedStraumann® BLC and TLC Implants - Line extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · DZE Implant, Endosseous, Root-Form
Cleared on Mar 20, 2024 as substantially equivalent to K230108 (Institut Straumann AG, 2023) after a 90-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Mar 20, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K894595 (1990). 91 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- 2 generations backK150938 Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC · 2015 · Recalled
- 1 generation backK230108 Straumann® BLC and TLC ImplantsInstitut Straumann AG · 2023
- This deviceK234049 Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG · 2024
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 12 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 11 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 10 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 9 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 8 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 7 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 6 generations backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- 5 generations backK123784 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 4 generations backK130222 Straumann Dental Implant SystemStraumann USA, LLC · 2013
- 3 generations backK140878 Straumann Bone Level Tapered ImplantStraumann USA, LLC · 2014 · Recalled
- 2 generations backK150938 Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC · 2015 · Recalled
- 1 generation backK230108 Straumann® BLC and TLC ImplantsInstitut Straumann AG · 2023
- This deviceK234049 Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −12 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −11 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −10 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −9 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −8 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −7 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −6 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| −5 | K123784 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −4 | K130222 | Straumann Dental Implant System | Straumann USA, LLC | 2013 | — |
| −3 | K140878 | Straumann Bone Level Tapered Implant | Straumann USA, LLC | 2014 | 2 |
| −2 | K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | Straumann USA, LLC | 2015 | 2 |
| −1 | K230108 | Straumann® BLC and TLC Implants | Institut Straumann AG | 2023 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K230108 | Straumann® BLC and TLC ImplantsSummary page 6…Straumann® BLC and TLC Implants - Line extension 510(k) Summary 3 Predicate Device(s) Primary Predicate: • K230108 - Straumann® BLC and TLC Implants Reference Devices: • K212533 - BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implant… | 2023 |
| † | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | 2022 |
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 34 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 15 of the 91 ancestors have a recall of any class.
- 1 other device also cites its predicate K230108.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.
They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234049 · printed Nov 5, 2026
Cite this page
510(k) Report. “K234049: Straumann® BLC and TLC Implants - Line extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K234049
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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