510(k) · Cleared
ClearedTRI-matrix Implant Line
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 21, 2021 as substantially equivalent to K151916 (Tri Dental Implants Int. AG, 2015) and 1 other predicate after a 371-day review. Its family tree reaches back 15 generations to 1990. 3 later devices descend from it.
- Decided
- Dec 21, 2021
- Review
- 371 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K894595 (1990). 177 ancestors in all, the oldest K781060 (1978). 3 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 2 generations backK160626 ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016
- 1 generation backK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- This deviceK203660 TRI-matrix Implant LineTri Dental Implants Int. AG · 2021
- Descendant · cites it directly · 0 of its ownK242661 TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG · 2025
- Descendant · cites it directly · 0 of its ownK241170 Dynamic TiBase; TRI ScrewsTalladium España, SL · 2024
- Descendant · cites it directly · 0 of its ownK233231 Dental Implants and AbutmentsDitron Dental, Ltd. · 2024
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 11 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 10 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 9 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 8 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 7 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 6 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 5 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 4 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 3 generations backK130999 Osseospeed Profile EVDentsply Implants Manufacturing GmbH · 2013
- 2 generations backK160626 ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona · 2016
- 1 generation backK172225 Atlantis Abutment for MIS ImplantDentsply Sirona · 2017
- This deviceK203660 TRI-matrix Implant LineTri Dental Implants Int. AG · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −11 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −10 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −9 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −8 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −7 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −6 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −5 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −4 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −3 | K130999 | Osseospeed Profile EV | Dentsply Implants Manufacturing GmbH | 2013 | — |
| −2 | K160626 | ATLANTIS Abutment for HIOSSEN ET implant | Dentsply Sirona | 2016 | — |
| −1 | K172225 | Atlantis Abutment for MIS Implant | Dentsply Sirona | 2017 | — |
| 0 (this device) | K203660 | TRI-matrix Implant Line | Tri Dental Implants Int. AG | 2021 | — |
| +1 | K242661 | TRI-matrix® X-Force Implants | Tri Dental Implants Int. AG | 2025 | — |
| +1 | K241170 | Dynamic TiBase; TRI Screws | Talladium España, SL | 2024 | — |
| +1 | K233231 | Dental Implants and Abutments | Ditron Dental, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 12 | 0 |
| 1996 | 11 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2001 | 9 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K151916 | TRI Dental Implant SystemSummary page 4…Dental Products Panel Reviewing Division DHT1B: Division of Dental Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K151916, TRI® Dental Implant System, TRI Dental Implants Int. AG Additional Predicate Device K172225, ATLANTIS® Abutment for MIS Implant,… | 2015 |
| * | K172225 | Atlantis Abutment for MIS ImplantSummary page 4…on of Dental Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K151916, TRI® Dental Implant System, TRI Dental Implants Int. AG Additional Predicate Device K172225, ATLANTIS® Abutment for MIS Implant, Dentsply Sirona INDICATIONS FOR USE STATEMENT The TRI-matrix® Implant Line is intended for… | 2017 |
What descends from it? (3)
3 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 31 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 22 of the 177 ancestors have a recall of any class.
- Of its descendants, K242661 (Tri Dental Implants Int. AG, 2025) has gone furthest, with 0 descendants of its own.
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?
The TRI-matrix® Implant Line is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® Implant Line 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-matrix® Implant Line 6.5 mm implants…
Read the full statement (119 words)
The TRI-matrix® Implant Line is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® Implant Line 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-matrix® Implant Line 6.5 mm implants are intended for delayed loading only.
The TRI-matrix® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the TRI-matrix® Crown Abutment to the endosseous implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203660: TRI-matrix Implant Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203660
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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