510(k) · Cleared
ClearedStraumann TLX Novaloc and Cementable 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 Feb 12, 2021 as substantially equivalent to K193046 (Institut Straumann AG, 2020) after an 88-day review. Its family tree reaches back 2 generations to 2019. 2 later devices descend from it.
- Decided
- Feb 12, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K190040 (2019). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK190040 Straumann BLX Line Extension - New AbutmentsInstitut Straumann AG · 2019
- 1 generation backK193046 Straumann® Retentive System – Novaloc TiN AbutmentsInstitut Straumann AG · 2020
- This deviceK203355 Straumann TLX Novaloc and Cementable AbutmentsInstitut Straumann AG · 2021
- Descendant · cites it directly · 1 of its ownK213063 TLX SRAs and TLX Gold AbutmentsInstitut Straumann AG · 2022
- Descendant · 2 generations on · 0 of its ownK231566 ICX-Implant SystemMedentis Medical GmbH · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K190040 | Straumann BLX Line Extension - New Abutments | Institut Straumann AG | 2019 | — |
| −1 | K193046 | Straumann® Retentive System – Novaloc TiN Abutments | Institut Straumann AG | 2020 | — |
| 0 (this device) | K203355 | Straumann TLX Novaloc and Cementable Abutments | Institut Straumann AG | 2021 | — |
| +1 | K213063 | TLX SRAs and TLX Gold Abutments | Institut Straumann AG | 2022 | — |
| +2 | K231566 | ICX-Implant System | Medentis Medical GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 30.7 · 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 |
|---|---|---|---|
| * | K193046 | Straumann® Retentive System – Novaloc TiN AbutmentsSummary page 5…Straumann TLX Novaloc and Cementable Abutments 510(k) Summary 5.3 Predicate Device(s) Primary Predicate: • K193046 - Straumann® Retentive System – Novaloc TiN Abutments Reference Devices: • K113283 - Narrow Neck CrossFit (NNC) Cementable… | 2020 |
| † | K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC… | 2011 |
| † | K200586 | Straumann TLX Implant System | 2020 |
| † | K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213063 | TLX SRAs and TLX Gold Abutments | 2022 | 1 |
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 2 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K213063 (Institut Straumann AG, 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K193046.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 (NT, RT, and WT).
Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Final abutments may be placed into occlusion for implants with sufficient primary stability and with appropriate occlusal loading to restore chewing function or for implants that are fully osseointegrated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203355: Straumann TLX Novaloc and Cementable Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203355
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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