510(k) · Cleared
ClearedBego Semados S-Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bego Implant Systems GmbH & Co. KG · DZE Implant, Endosseous, Root-Form
Cleared on Oct 6, 2009 as substantially equivalent to K032158 (Friadent GmbH, 2003) after a 202-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.
- Decided
- Oct 6, 2009
- Review
- 202 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K894595 (1990). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 4 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 3 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 1 generation backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- This deviceK090716 Bego Semados S-LineBego Implant Systems GmbH & Co. KG · 2009
- Descendant · cites it directly · 0 of its ownK201700 BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG · 2021
Most influential descendants
Showing 1 of 1 · See all- K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −5 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −4 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −3 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −1 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| 0 (this device) | K090716 | Bego Semados S-Line | Bego Implant Systems GmbH & Co. KG | 2009 | — |
| +1 | K201700 | BEGO Semados® RS/RSX Implant System | Bego Implant Systems GmbH & Co. KG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (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 |
|---|---|---|---|
| * | K032158 | Xive Dental Implant System MultipleSummary page 2…05 Legally marketed device to which your firm is claiming equivalence Company: Friadent GmbH Device: XIVE Dental Implant System® 510(k) No.: K032158 Device Description BEGO Semados® S-Line with TiPureplus Surface is a dental implant system that can be placed subgingivally i… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201700 | BEGO Semados® RS/RSX Implant System | 2021 | 0 |
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 19 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K201700 (Bego Implant Systems GmbH & Co. KG, 2021) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K032158.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Bego Semados® S-line threaded endosseous dental implants are indicated for restorations in the upper and lower jaw (single tooth replacement, abutments for bridgework, partial or complete edentolism)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090716: Bego Semados S-Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090716
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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