510(k) · Cleared
ClearedStraumann BLX Line Extension - New Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 8, 2019 after a 90-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Apr 8, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK190040 Straumann BLX Line Extension - New AbutmentsInstitut Straumann AG · 2019
- Descendant · cites it directly · 3 of its ownK193046 Straumann® Retentive System – Novaloc TiN AbutmentsInstitut Straumann AG · 2020
- Descendant · 2 generations on · 2 of its ownK203355 Straumann TLX Novaloc and Cementable AbutmentsInstitut Straumann AG · 2021
- Descendant · 3 generations on · 1 of its ownK213063 TLX SRAs and TLX Gold AbutmentsInstitut Straumann AG · 2022
- Descendant · cites it directly · 0 of its ownK253315 Straumann Variobase Abutments XC for Bridge/BarInstitut Straumann AG · 2026
- Descendant · 2 generations on · 0 of its ownK231566 ICX-Implant SystemMedentis Medical GmbH · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193046Straumann® Retentive System – Novaloc TiN AbutmentsInstitut Straumann AG · 2020 · cites it directly3descendants
- K203355Straumann TLX Novaloc and Cementable AbutmentsInstitut Straumann AG · 2021 · 2 generations on2descendants
- K213063TLX SRAs and TLX Gold AbutmentsInstitut Straumann AG · 2022 · 3 generations on1descendant
- K253315Straumann Variobase Abutments XC for Bridge/BarInstitut Straumann AG · 2026 · cites it directly0descendants
- K231566ICX-Implant SystemMedentis Medical GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K190040 | Straumann BLX Line Extension - New Abutments | Institut Straumann AG | 2019 | — |
| +1 | K193046 | Straumann® Retentive System – Novaloc TiN Abutments | Institut Straumann AG | 2020 | — |
| +2 | K203355 | Straumann TLX Novaloc and Cementable Abutments | Institut Straumann AG | 2021 | — |
| +3 | K213063 | TLX SRAs and TLX Gold Abutments | Institut Straumann AG | 2022 | — |
| +1 | K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 2026 | — |
| +2 | K231566 | ICX-Implant System | Medentis Medical GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (6)
3 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?
- Of its descendants, K193046 (Institut Straumann AG, 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
https://510kreport.com/device/K190040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190040: Straumann BLX Line Extension - New Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190040
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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