510(k) · Cleared
ClearedTRI Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tri Dental Implants Int. AG · DZE Implant, Endosseous, Root-Form
Cleared on Dec 18, 2015 as substantially equivalent to K101880 (Zimmer Dental, Inc., 2010) and 2 other predicates after a 158-day review. Its family tree reaches back 9 generations to 1990. 4 later devices descend from it.
- Decided
- Dec 18, 2015
- Review
- 158 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K894595 (1990). 41 ancestors in all, the oldest K894844 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 1 generation backK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · Recalled
- This deviceK151916 TRI Dental Implant SystemTri Dental Implants Int. AG · 2015
- Descendant · cites it directly · 3 of its ownK203660 TRI-matrix Implant LineTri Dental Implants Int. AG · 2021
- Descendant · 2 generations on · 0 of its ownK242661 TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG · 2025
- Descendant · 2 generations on · 0 of its ownK241170 Dynamic TiBase; TRI ScrewsTalladium España, SL · 2024
- Descendant · 2 generations on · 0 of its ownK233231 Dental Implants and AbutmentsDitron Dental, Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 1 generation backK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · Recalled
- This deviceK151916 TRI Dental Implant SystemTri Dental Implants Int. AG · 2015
Most influential descendants
Showing 4 of 4 · See all- K203660TRI-matrix Implant LineTri Dental Implants Int. AG · 2021 · cites it directly3descendants
- K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG · 2025 · 2 generations on0descendants
- K241170Dynamic TiBase; TRI ScrewsTalladium España, SL · 2024 · 2 generations on0descendants
- K233231Dental Implants and AbutmentsDitron Dental, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K062566 | Nobelreplace Tapered Conical Connection | Nobel Biocare USA, LLC | 2006 | 27 |
| −1 | K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant | Zimmer Dental, Inc. | 2010 | 1 |
| 0 (this device) | K151916 | TRI Dental Implant System | Tri Dental Implants Int. AG | 2015 | — |
| +1 | K203660 | TRI-matrix Implant Line | Tri Dental Implants Int. AG | 2021 | — |
| +2 | K242661 | TRI-matrix® X-Force Implants | Tri Dental Implants Int. AG | 2025 | — |
| +2 | K241170 | Dynamic TiBase; TRI Screws | Talladium España, SL | 2024 | — |
| +2 | K233231 | Dental Implants and Abutments | Ditron Dental, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantSummary page 4…assification Panel Dental Products Panel Reviewing Branch Dental Devices Branch The primary predicate for the TRI®-Narrow and TRI®-Vent implants is: K101880, Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant, Zimmer Dental, Inc. The primary predicate for the TRI®-Octa im… | 2010 |
| * | K012757 | Iti Dental Implant SystemSummary page 4…RI®-Vent implants is: K101880, Tapered Screw-Vent® T Implant and Tapered Screw-Vent® P Implant, Zimmer Dental, Inc. The primary predicate for the TRI®-Octa implants is: K012757, ITI® Dental Implant System, Straumann USA. The primary predicate for TRI®-Dental Implant System abutments is: K083496, CAMLOG I… | 2001 |
| * | K083496 | Camlog Implant System Modified Implants and AbutmentsSummary page 4…primary predicate for the TRI®-Octa implants is: K012757, ITI® Dental Implant System, Straumann USA. The primary predicate for TRI®-Dental Implant System abutments is: K083496, CAMLOG Implant System Modified Implants and Abutments, Altatec GmbH. 510(k) Summary… | 2009 |
| † | K101545 | Genesis Implant System | 2010 |
| † | K113779 | Conelog Implant System | 2012 |
| † | K072570 | Nobelactive Multi Unit Abutment | 2007 |
| † | K092035 | Bicon Implants with a 2.5MM Internal Connection | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203660 | TRI-matrix Implant Line | 2021 | 3 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 41 ancestors have a recall of any class.
- Of its descendants, K203660 (Tri Dental Implants Int. AG, 2021) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K101880.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 TRI® Dental Implant System is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI® Dental Implant System allows for one and two-stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.
TRI Dental Implant System 6.5 mm implants are intended for delayed loading only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151916: TRI Dental 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/K151916
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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