510(k) · Cleared
ClearedBEGO Semados® RS/RSX Implant System
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 Jan 13, 2021 as substantially equivalent to K142260 (Nobel Biocare AB, 2015) and 1 other predicate after a 205-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Jan 13, 2021
- Review
- 205 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K894595 (1990). 95 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- 2 generations backK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- 1 generation backK142260 NobelActiveNobel Biocare AB · 2015
- This deviceK201700 BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG · 2021
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 7 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 6 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 5 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 4 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 3 generations backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- 2 generations backK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- 1 generation backK142260 NobelActiveNobel Biocare AB · 2015
- This deviceK201700 BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −7 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −5 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −4 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −3 | K083205 | Nobelactive 8.5 MM & 18.0 MM | Nobel Biocare AB | 2009 | — |
| −2 | K133731 | Nobelactive Wide Platform (WP) | Nobel Biocare AB | 2014 | — |
| −1 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 7 | 0 |
| 1996 | 11 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K142260 | NobelActiveSummary page 5…Dental 7. Legally marketed predicate devices Table 5A – List of devices chosen from the primary predicate devices 510(k) number of primary predicate device: K142260 Device name: NobelActive Trade name of the Trade name of the primary… | 2015 |
| * | K090716 | Bego Semados S-LineSummary page 5…BEGO Semados® NobelActive® Nobel Biocare AB, SWEDEN RS/RSX implants 510(k) number of primary predicate device: K090716 Device name: BEGO Semados® S-Line Trade name of the Trade name of the primary… | 2009 |
| † | K161435 | Temporary Snap Abutment | 2016 |
| † | K102436 | Nobel Active 3.0 | 2010 |
| † | K161416 | Multi-unit Abutment Plus | 2017 |
| † | K072878 | Modification to: Locator Implant Anchor | 2007 |
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 31 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 12 of the 95 ancestors have a recall of any class.
- 9 other devices also cite its predicate K142260.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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@ RS/RSX Implant System consists of implants, healing posts and abutments. The BEGO Semados@ RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading, depending on sufficient primary stability and appropriate occlusal loading. The BEGO…
Read the full statement (150 words)
The BEGO Semados@ RS/RSX Implant System consists of implants, healing posts and abutments.
The BEGO Semados@ RS/RSX implant is indicated for single or multiple unit restorations on splinted or non-splinted applications both in the upper and lower jaw. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading, depending on sufficient primary stability and appropriate occlusal loading.
The BEGO Semados@ RS/RSX implant 3.0 is only indicated for single unit restorations of the lower lateral, central incisors or upper lateral incisors.
The healing posts are indicated for patients treated with BEGO Semados@ RS/RSX implants for the time during healing of the surrounding soft tissue.
The abutments are indicated for patients treated with BEGO Semados@ RS/RSX implants as an aid in prosthetic rehabilitation.
PS ITA, PS TTiA and PS TTiA NH are intended to be used for a maximum period of 6 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201700 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201700: BEGO Semados® RS/RSX Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201700
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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