510(k) · Cleared
ClearedTriActive Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Implant Mfg., LLC · DZE Implant, Endosseous, Root-Form
Cleared on Sep 17, 2026 as substantially equivalent to K251938 (Paragon Implant Mfg., LLC, 2025) and 1 other predicate after a 141-day review. Its family tree reaches back 16 generations to 1996.
- Decided
- Sep 17, 2026
- Review
- 141 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K960026 (1996). 325 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations between
- 3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 2 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- This deviceK261392 TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
Show all 16 generations
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 14 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 13 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 9 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 8 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 7 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 6 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 5 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 4 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 2 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- This deviceK261392 TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −15 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −9 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −8 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −7 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −6 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −5 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −4 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −3 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −2 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| 0 (this device) | K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | 2026 | — |
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 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 19 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 18 | 0 |
| 2007 | 24 | 0 |
| 2008 | 16 | 0 |
| 2009 | 14 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K251938 | GEN5 and GEN5+ Dental Implant SystemSummary page 6…Class II Product Code(s) DZE; NHA Legally Marketed Predicate Device(s) Primary Predicate Device (DZE - Implants) K251938 (GEN5 and GEN5+ Dental Implant System), Paragon Implant Mfg, LLC Reference Device… | 2025 |
| * | K170588 | DESS Dental Smart SolutionsSummary page 7…ntal Implant System K261392 Page 2 of 25 Reference Devices (NHA – Abutments) K170588 (DESS Dental Smart Solutions), Terrats Medical SL… | 2017 |
| † | K142260 | NobelActive | 2015 |
| † | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2… | 2020 |
| † | K130572 | Interactive/ SWISHPLUS2 Implant System | 2013 |
| † | K202344 | TiUltra Implants and Xeal Abutments | 2020 |
| † | K173908 | DESS Dental Smart Solutions | 2018 |
| † | K191986 | DESS Dental Smart Solutions | 2019 |
| † | K203464 | DESS Dental Smart Solutions | 2021 |
| † | K212628 | DESS Dental Smart Solutions | 2022 |
| † | K233316 | DESS Dental Smart Solutions | 2024 |
| † | K240208 | DESS Dental Smart Solutions | 2024 |
| † | K252384 | DESS® Dental Smart Solutions | 2025 |
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 30 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 46 of the 325 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
TriActive implants are two-piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. Short (<8.5mmL)…
Read the full statement (334 words)
TriActive implants are two-piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading.
Short (<8.5mmL) TriActive Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
Narrow (<3.7mmD) TriActive Implants are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization.
The TriActive Abutment System is intended for use with TriActive dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques.
All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical SL validated milling center for manufacture.
The TriActive Implant bodies are indicated for compatibility with the following abutments systems:
* Ti-base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
* Ti-blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
» CoCr Base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
* CoCr Blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
* Angled Multi-Unit Abutments manufactured by Terrats Medical SL., platform NP and RP, Angled, max 30 degrees
o Active Hex
» Stock Straight Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
* Locator Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261392: TriActive 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/K261392
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026