510(k) · Cleared
ClearedStraumann® Retentive System – Novaloc TiN 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 Aug 13, 2020 as substantially equivalent to K190040 (Institut Straumann AG, 2019) after a 286-day review. Its family tree reaches back 1 generation to 2019. 3 later devices descend from it.
- Decided
- Aug 13, 2020
- Review
- 286 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190040 (2019). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK190040 Straumann BLX Line Extension - New AbutmentsInstitut Straumann AG · 2019
- This deviceK193046 Straumann® Retentive System – Novaloc TiN AbutmentsInstitut Straumann AG · 2020
- Descendant · cites it directly · 2 of its ownK203355 Straumann TLX Novaloc and Cementable AbutmentsInstitut Straumann AG · 2021
- Descendant · 2 generations on · 1 of its ownK213063 TLX SRAs and TLX Gold AbutmentsInstitut Straumann AG · 2022
- Descendant · cites it directly · 0 of its ownK231566 ICX-Implant SystemMedentis Medical GmbH · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190040 | Straumann BLX Line Extension - New Abutments | Institut Straumann AG | 2019 | — |
| 0 (this device) | K193046 | Straumann® Retentive System – Novaloc TiN Abutments | Institut Straumann AG | 2020 | — |
| +1 | K203355 | Straumann TLX Novaloc and Cementable Abutments | Institut Straumann AG | 2021 | — |
| +2 | K213063 | TLX SRAs and TLX Gold Abutments | Institut Straumann AG | 2022 | — |
| +1 | K231566 | ICX-Implant System | Medentis Medical GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K190040 | Straumann BLX Line Extension - New AbutmentsSummary page 5…Straumann Retentive System – Novaloc TiN Abutments 510(k) Summary 5.3 Predicate Device(s) Primary Predicate: K190040 - Straumann BLX Line Extension - New Abutments Reference Devices: K033699 – Locator Bar Female K151157 – S… | 2019 |
| † | K033699 | Locator Bar Female, Locator Laser Bar Female, Locator Bar Cast-to Female, Models 08587… | 2004 |
| † | K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for… | 2015 |
| † | K171649 | Straumann CARES M-Series CAD/CAM System | 2018 |
| † | K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | 2019 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 | — |
What is it indicated for?
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants and bar constructs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193046: Straumann® Retentive System – Novaloc TiN Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193046
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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