510(k) · Cleared
ClearedTiarray Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nasseo, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 7, 2013 as substantially equivalent to K061003 (Nobel Biocare AB, 2006) and 2 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Aug 7, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894595 (1990). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 4 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 3 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 2 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 1 generation backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- This deviceK131345 Tiarray Dental Implant SystemNasseo, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −2 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −1 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| 0 (this device) | K131345 | Tiarray Dental Implant System | Nasseo, Inc. | 2013 | — |
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 |
| 2005 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K061003 | SFB & CFB ImplantsSummary page 2…ant. EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: * Nobel Biocare USA LLC., SF8 & CEB Implants (K06 1003) * Nobel Biocare USA LLC., NobelActive Internal Connection Implant (K07 1370) * Implant Direct LLC., Spectra-System (K06131… | 2006 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 2…lent to the following predicate devices: * Nobel Biocare USA LLC., SF8 & CEB Implants (K06 1003) * Nobel Biocare USA LLC., NobelActive Internal Connection Implant (K07 1370) * Implant Direct LLC., Spectra-System (K061319) The implants of the subject TiArray Dental Implant System have a similar des… | 2007 |
| * | K061319 | Spectra SystemSummary page 2…Biocare USA LLC., SF8 & CEB Implants (K06 1003) * Nobel Biocare USA LLC., NobelActive Internal Connection Implant (K07 1370) * Implant Direct LLC., Spectra-System (K061319) The implants of the subject TiArray Dental Implant System have a similar design (threaded body with micro-grooves at the collar… | 2006 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 23 ancestors have a recall of any class.
- 6 other devices also cite its predicate K061003.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 TiArray Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131345: Tiarray Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131345
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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