510(k) · Cleared
Recalled · 2007Tiunite 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 May 19, 2005 as substantially equivalent to K041661 (Nobel Biocare Uas, Inc., 2004) after a 62-day review. Its family tree reaches back 5 generations to 1990. 532 later devices descend from it. It has been recalled once.
- Decided
- May 19, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894595 (1990). 18 ancestors in all. 532 later devices descend from it, 10 citing it directly.
- Root · 5 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 4 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 3 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 2 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 1 generation backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- This deviceK050705 Tiunite ImplantsNobel Biocare AB · 2005
- Descendant · cites it directly · 507 of its ownK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- Descendant · 2 generations on · 414 of its ownK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- Descendant · 2 generations on · 327 of its ownK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- Descendant · 3 generations on · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- Descendant · 4 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
Showing 5 of 532 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 532 · See all- K061003SFB & CFB ImplantsNobel Biocare AB · 2006 · cites it directly507descendants
- K071370Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · 2 generations on414descendants
- K062749SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP, Model…Nobel Biocare AB · 2006 · 2 generations on327descendants
- K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · 3 generations on278descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 4 generations on240descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −4 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −3 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −2 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −1 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| 0 (this device) | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | — |
| +1 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| +2 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| +2 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| +3 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| +4 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 11 | 0 |
| 2011 | 16 | 0 |
| 2012 | 12 | 0 |
| 2013 | 25 | 0 |
| 2014 | 21 | 0 |
| 2015 | 29 | 0 |
| 2016 | 29 | 0 |
| 2017 | 26 | 0 |
| 2018 | 25 | 0 |
| 2019 | 27 | 0 |
| 2020 | 35 | 0 |
| 2021 | 37 | 0 |
| 2022 | 38 | 0 |
| 2023 | 47 | 0 |
| 2024 | 61 | 0 |
| 2025 | 48 | 0 |
| 2026 | 23 | 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 |
|---|---|---|---|
| * | K041661 | Nobel Biocare Endosseous ImplantsSummary page 1…CFR 8723640) Trade or Proprietary or Model Name: TiUnite' Implants Legally Marketed Device(s): Nobel Biocare Endosseous Implants (K041661) Device Description: Nobel Biocare TiUnite" Implants are threaded, root-form dental implants intended for use in the upper and/o… | 2004 |
What descends from it? (532)
See all 53210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061003 | SFB & CFB Implants | 2006 | 507 |
| K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 | 122 |
| K170588 | DESS Dental Smart Solutions | 2017 | 86 |
| K173908 | DESS Dental Smart Solutions | 2018 | 51 |
| K093630 | Biodenta Dental Implant System | 2010 | 18 |
| K101545 | Genesis Implant System | 2010 | 15 |
| K122988 | Klockner Dental Implant Abutments | 2013 | 9 |
| K070184 | Dental Implant, Dental Abutment, Abutment Screw, Cover Screw, Healing Abutment | 2008 | 1 |
| K180968 | AlphaDent Implants Dental Implants System | 2019 | 0 |
| K081128 | Molar Implant | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2007 | Not classified | Z-2240-2008 | Labeling mix-ups | This recall was initiated after it was discovered that the NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect cap label. The affected lot has a cap label identifying the implant as "4.3x8". Since this cap label… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K061003 (Nobel Biocare AB, 2006) has gone furthest, with 507 descendants of its own.
- 7 other devices also cite its predicate K041661.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Nobel Biocare TiUnite® Implants are root-form endosseous 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. Nobel Biocare TiUnite Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare TiUnite® Implants may be placed…
Read the full statement (141 words)
Nobel Biocare TiUnite® Implants are root-form endosseous 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. Nobel Biocare TiUnite Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare TiUnite® Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
TiUnite® implants are indicated for use in soft bone whenever immediate or early loading is applied. The TiUnite® implants are preferred in these soft bone indications because bone formation is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050705 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050705: Tiunite Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050705
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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