510(k) · Cleared
Recalled · Class II · 2025N1 TiUltra TCC Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare Services AG · DZE Implant, Endosseous, Root-Form
Cleared on Dec 21, 2021 as substantially equivalent to K142260 (Nobel Biocare AB, 2015) and 6 other predicates after a 251-day review. Its family tree reaches back 13 generations to 1990. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 21, 2021
- Review
- 251 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 13 generations to K894595 (1990). 98 ancestors in all, the oldest K871863 (1987). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK211109 N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021
- Descendant · cites it directly · 1 of its ownK220048 NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022
- Descendant · cites it directly · 0 of its ownK253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging…Nobel 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 deviceK211109 N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021
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 |
|---|---|---|---|---|---|
| −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) | K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | 2021 | — |
| +1 | K220048 | NobelProcera Zirconia N1 Base | Nobel Biocare Services AG | 2022 | — |
| +1 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base… | 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 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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? (7)
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 7…ystem (N1™ system) Device 510(k) Manufacturer Primary Predicate NobelActive K142260 Nobel Biocare AB Reference #1 TiUltra Implants and Xeal Abutments K202344 Nobel Biocare AB Reference #2… | 2015 |
| * | K202344 | TiUltra Implants and Xeal AbutmentsSummary page 7…Manufacturer Primary Predicate NobelActive K142260 Nobel Biocare AB Reference #1 TiUltra Implants and Xeal Abutments K202344 Nobel Biocare AB Reference #2 NobelActive Wide Platform (WP) K133731 Nobel Biocare AB Reference #3… | 2020 |
| * | K200040 | Universal Base Conical Connection (CC)Summary page 7…iocare AB Reference #4 Branemark Novum K000018 Nobel Biocare UAS Inc. Reference #5 Universal Base Conical Connection (CC) K200040 Nobel Biocare AG Reference #6 On1 Universal Abutment K181869 Nobel Biocare AB Reference #7… | 2020 |
| * | K133731 | Nobelactive Wide Platform (WP)Summary page 7…obel Biocare AB Reference #1 TiUltra Implants and Xeal Abutments K202344 Nobel Biocare AB Reference #2 NobelActive Wide Platform (WP) K133731 Nobel Biocare AB Reference #3 On1 Concept K161655 Nobel Biocare AB Reference #4… | 2014 |
| * | K181869 | On1 Universal AbutmentSummary page 7…iocare UAS Inc. Reference #5 Universal Base Conical Connection (CC) K200040 Nobel Biocare AG Reference #6 On1 Universal Abutment K181869 Nobel Biocare AB Reference #7 Multi-unit Abutment Plus K161416 Nobel Biocare AB… | 2018 |
| * | K161655 | On1 ConceptSummary page 7…obel Biocare AB Reference #2 NobelActive Wide Platform (WP) K133731 Nobel Biocare AB Reference #3 On1 Concept K161655 Nobel Biocare AB Reference #4 Branemark Novum K000018 Nobel Biocare UAS Inc. Referenc… | 2017 |
| * | K161416 | Multi-unit Abutment PlusSummary page 7…obel Biocare AG Reference #6 On1 Universal Abutment K181869 Nobel Biocare AB Reference #7 Multi-unit Abutment Plus K161416 Nobel Biocare AB Nobel Biocare Dental Implant Systems Reference #8… | 2017 |
| † | K000018 | Branemark Novum | 2000 |
| † | K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | 2021 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 10, 2025 | Class II | Z-1101-2025 | Process control | Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product. |
| Jul 25, 2022 | Class II | Z-1565-2022 | Process change control | Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. |
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.
- 16 of the 98 ancestors have a recall of any class.
- Of its descendants, K220048 (Nobel Biocare Services AG, 2022) has gone furthest, with 1 descendant 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. 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?
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary…
Read the full statement (711 words)
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
The N1™ system Implant Site Preparation Tools are indicated to be used in the maxilla or mandible to prepare an osteotomy prior to placement of a Nobel Biocare N1™ TiUltra™ TCC implant.
To be used when applicable together with the implant during healing in order to protect the implant platform and internal threads from overgrowth of bone.
Multi-unit Abutment TCC is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Universal abutments are indicated to support the placement of single unit, screw-retained prosthetic restorations in the maxilla or mandible.
The Universal Abutment consists of two major parts. Specifically, the titanium base and mesostructure components make up a two-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.
The Universal Abutment Nobel Biocare N1™ Base consist of three major parts. Specifically, the N1 Base Xeal, the Universal Abutment N1 Base, 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.
The Nobel Biocare N1™ Base Xeal™ is indicated for use in the maxilla or mandible for supporting tooth replacements to restore chewing function. It is indicated for single unit restorations and multiple unit restorations up to 6 units with less than 20° divergence to allow path of insertion.
The Universal Abutment Nobel Biocare N1™ Base Tri is indicated to support the placement of single unit, screw-retained prosthetic restorations in the maxilla or mandible.
The Universal Abutment Nobel Biocare N1™ Base Tri Bridge is indicated to support the placement of multiple unit of up to 6 units, screw-retained prosthetic restorations in the maxilla or mandible for implants with less than 20° overall divergences to allow path of insertion.
Healing abutments are indicated for use with endosseous dental implants in the maxilla or mandible for supporting single tooth to full arch denture procedures. Healing abutments Nobel Biocare N1™ TCC are indicated for use for up to 180 days.
Are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days.
The Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days.
The Temporary Abutment Nobel Biocare N1™ Base is indicated to support the placement of single unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days.
The Temporary Abutment Nobel Biocare N1™ Base Bridge is indicated to support the placement of multiple unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days for implants with less than 20° overall divergences to allow path of insertion.
The IOS Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days. In combination with intraoral scanner the IOS Healing Abutment can be used to confirm the location, position, and orientation of the Nobel Biocare N1™ Base Xeal™, to support creation of the digital model to facilitate the design and fabrication of a dental prosthesis using CAD/CAM.
The Clinical and Prosthetic Screw are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
Clinical Screws are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211109: N1 TiUltra TCC Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211109
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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