510(k) · Cleared
ClearedTiUltra Implants and Xeal Abutments
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 Nov 16, 2020 as substantially equivalent to K142260 (Nobel Biocare AB, 2015) and 4 other predicates after a 90-day review. Its family tree reaches back 12 generations to 1990. 4 later devices descend from it.
- Decided
- Nov 16, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K894595 (1990). 95 ancestors in all, the oldest K871863 (1987). 4 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- 2 generations backK142260 NobelActiveNobel Biocare AB · 2015
- 1 generation backK173418 NobelParallel Conical ConnectionNobel Biocare AB · 2019 · Recalled
- This deviceK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
- Descendant · cites it directly · 2 of its ownK211109 N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK220048 NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022
- Descendant · 2 generations on · 0 of its ownK253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging…Nobel Biocare AB · 2026
- Descendant · cites it directly · 0 of its ownK252197 Nobel Biocare S Series ImplantsNobel Biocare AB · 2026
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 4 generations backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- 3 generations backK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- 2 generations backK142260 NobelActiveNobel Biocare AB · 2015
- 1 generation backK173418 NobelParallel Conical ConnectionNobel Biocare AB · 2019 · Recalled
- This deviceK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
Most influential descendants
Showing 4 of 4 · See all- K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · cites it directly2descendants
- K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022 · 2 generations on1descendant
- K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB · 2026 · 2 generations on0descendants
- K252197Nobel Biocare S Series ImplantsNobel Biocare AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −4 | K083205 | Nobelactive 8.5 MM & 18.0 MM | Nobel Biocare AB | 2009 | — |
| −3 | K133731 | Nobelactive Wide Platform (WP) | Nobel Biocare AB | 2014 | — |
| −2 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
| −1 | K173418 | NobelParallel Conical Connection | Nobel Biocare AB | 2019 | 1 |
| 0 (this device) | K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare AB | 2020 | — |
| +1 | K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | 2021 | 2 |
| +2 | K220048 | NobelProcera Zirconia N1 Base | Nobel Biocare Services AG | 2022 | — |
| +2 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base… | Nobel Biocare AB | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 2 | 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? (5)
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 6…implants and Xeal abutments Device 510(k) Manufacturer Primary Predicate NobelActive K142260 Nobel Biocare AB Predicate #2 NobelReplace Hexagonal Implant K073142 Nobel Biocare AB Predicate #3 and Ref… | 2015 |
| * | K073142 | Nobelreplace Hexagonal ImplantSummary page 6…510(k) Manufacturer Primary Predicate NobelActive K142260 Nobel Biocare AB Predicate #2 NobelReplace Hexagonal Implant K073142 Nobel Biocare AB Predicate #3 and Reference #2 NobelParallel Conical Connection K173418 Nobel Biocare AB Pre… | 2008 |
| * | K173418 | NobelParallel Conical ConnectionSummary page 6…re AB Predicate #2 NobelReplace Hexagonal Implant K073142 Nobel Biocare AB Predicate #3 and Reference #2 NobelParallel Conical Connection K173418 Nobel Biocare AB Predicate #4 Multi-unit Abutment Plus K161416 Nobel Biocare AB Predicate #5 On… | 2019 |
| * | K161416 | Multi-unit Abutment PlusSummary page 6…re AB Predicate #3 and Reference #2 NobelParallel Conical Connection K173418 Nobel Biocare AB Predicate #4 Multi-unit Abutment Plus K161416 Nobel Biocare AB Predicate #5 On1 Universal Abutment K181869 Nobel Biocare AB Reference #1 BT… | 2017 |
| * | K181869 | On1 Universal AbutmentSummary page 6…73418 Nobel Biocare AB Predicate #4 Multi-unit Abutment Plus K161416 Nobel Biocare AB Predicate #5 On1 Universal Abutment K181869 Nobel Biocare AB Reference #1 BTI Dental Implant System UnicCa ® K151391 B.T.I. Biotechnology Institute Referenc… | 2018 |
| † | K151391 | BTI Dental Implant System UnicCa | 2016 |
| † | K192347 | ST Internal Implant System | 2019 |
What descends from it? (4)
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 16 of the 95 ancestors have a recall of any class.
- Of its descendants, K211109 (Nobel Biocare Services AG, 2021) has gone furthest, with 2 descendants of its own.
- 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. 2020, 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 TiUltra NobelActive TiUltra 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 TiUltra 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…
Read the full statement (419 words)
NobelActive TiUltra
NobelActive TiUltra 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 TiUltra 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.
NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.
NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only.
NobelReplace CC TiUltra
NobelReplace CC TiUltra 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 CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC TiUltra implants can be used in splinted or non-splinted applications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
NobelParallel CC TiUltra
NobelParallel CC TiUltra 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 CC TiUltra implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by a 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 <7mm length are for delayed loading only when appropriate stability has been achieved.
MUA Xeal
The MUA Xeal is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
On1 Base Xeal
The On1 Base Xeal device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base Xeal, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202344: TiUltra Implants and Xeal Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202344
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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