510(k) · Cleared
ClearedNobel Biocare S Series Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · DZE Implant, Endosseous, Root-Form
Cleared on Feb 18, 2026 as substantially equivalent to K202344 (Nobel Biocare AB, 2020) after a 219-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Feb 18, 2026
- Review
- 219 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K894595 (1990). 96 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK142260 NobelActiveNobel Biocare AB · 2015
- 2 generations backK173418 NobelParallel Conical ConnectionNobel Biocare AB · 2019 · Recalled
- 1 generation backK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
- This deviceK252197 Nobel Biocare S Series ImplantsNobel Biocare AB · 2026
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 9 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 8 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 7 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 6 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 5 generations backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- 4 generations backK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- 3 generations backK142260 NobelActiveNobel Biocare AB · 2015
- 2 generations backK173418 NobelParallel Conical ConnectionNobel Biocare AB · 2019 · Recalled
- 1 generation backK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
- This deviceK252197 Nobel Biocare S Series ImplantsNobel Biocare AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −9 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −8 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −7 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −6 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −5 | K083205 | Nobelactive 8.5 MM & 18.0 MM | Nobel Biocare AB | 2009 | — |
| −4 | K133731 | Nobelactive Wide Platform (WP) | Nobel Biocare AB | 2014 | — |
| −3 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
| −2 | K173418 | NobelParallel Conical Connection | Nobel Biocare AB | 2019 | 1 |
| −1 | K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare AB | 2020 | — |
| 0 (this device) | K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | 2026 | — |
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 | 10 | 0 |
| 1994 | 10 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K202344 | TiUltra Implants and Xeal AbutmentsSummary page 6…gulation Number: 21 CFR 872.3640 Device Class: Class II Product Code: DZE 1.3 Predicate and Reference Devices Primary Predicate device K202344, TiUltra Implants and Xeal Abutments Reference Devices: 1 K230108 Straumann BLC and TLC Implants 2 K142260 NobelAc… | 2020 |
| † | K230108 | Straumann® BLC and TLC Implants | 2023 |
| † | K142260 | NobelActive | 2015 |
| † | K173418 | NobelParallel Conical Connection | 2019 |
| † | K073142 | Nobelreplace Hexagonal Implant | 2008 |
| † | K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | 2021 |
| † | K023113 | Replace Tiunite Endosseous Implant | 2002 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K083100 | Goldadapt Non-Engaging Nobelactive NP & RP, Goldadapt Engaging Nobelactive NP & RP | 2008 |
| † | K132746 | Nobelprocera Angulated Screw Channel Abutment Conical Connection | 2014 |
| † | K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | 2024 |
| † | K200040 | Universal Base Conical Connection (CC) | 2020 |
| † | K132749 | Nobelprocera Overdenture Bar | 2014 |
| † | K161416 | Multi-unit Abutment Plus | 2017 |
| † | K202452 | NobelProcera Zirconia Implant Bridge | 2020 |
| † | K240346 | NobelProcera Zirconia Implant Bridge | 2025 |
| † | K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | 2004 |
| † | K133731 | Nobelactive Wide Platform (WP) | 2014 |
| † | K061003 | SFB & CFB Implants | 2006 |
| † | K161435 | Temporary Snap Abutment | 2016 |
| † | K091756 | Nobelprocera TI Abutment | 2009 |
| † | K062566 | Nobelreplace Tapered Conical Connection | 2006 |
| † | K072570 | Nobelactive Multi Unit Abutment | 2007 |
| † | K160158 | NobelProcera HT ML FCZ Implant Bridge and Framework | 2016 |
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 36 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 16 of the 96 ancestors have a recall of any class.
- 1 other device also cites its predicate K202344.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical…
Read the full statement (301 words)
NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.
NobelActive® S TiUltra™ and NobelActive® S TiUnite® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications.
This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function.
The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants are indicated for single or multiple unit restorations.
The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants can be used in splinted or non-splinted applications.
The NobelReplace® S TiUltra™ and NobelReplace® S TiUnite® implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
NobelParallel™ S TiUltra™ and NobelParallel™ S TiUnite® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.
NobelParallel™ S TiUltra™ and NobelParallel™ S TiUnite® implants are indicated for single or multiple restorations in splinted or non-splinted applications.
This can be achieved by 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.
Implants with <7 mm length are for delayed loading only when appropriate stability has been achieved.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252197: Nobel Biocare S Series Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252197
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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