510(k) · Cleared
Recalled · Class II · 2021Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Direct Sybron Manufacturing, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Jun 25, 2020 as substantially equivalent to K090234 (Implant Direct, LLC, 2009) after a 315-day review. Its family tree reaches back 7 generations to 1990. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 25, 2020
- Review
- 315 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894595 (1990). 19 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 4 generations backK013227 Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 2001 · Recalled
- 3 generations backK073161 Replus Dental Implants (HA)Implant Direct, LLC · 2008
- 2 generations backK080713 Reactive Dental Implant SystemImplant Direct, LLC · 2008
- 1 generation backK090234 Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · Recalled
- This deviceK192221 Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental…Implant Direct Sybron Manufacturing, LLC · 2020
- Descendant · cites it directly · 1 of its ownK251938 GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC · 2025
- Descendant · 2 generations on · 0 of its ownK261392 TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
- Descendant · cites it directly · 0 of its ownK252145 GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC · 2025
Most influential descendants
Showing 3 of 3 · See all- K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC · 2025 · cites it directly1descendant
- K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026 · 2 generations on0descendants
- K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −4 | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | Sulzer Dental, Inc. | 2001 | 2 |
| −3 | K073161 | Replus Dental Implants (HA) | Implant Direct, LLC | 2008 | — |
| −2 | K080713 | Reactive Dental Implant System | Implant Direct, LLC | 2008 | — |
| −1 | K090234 | Spectra System Dental Implants 2008 | Implant Direct, LLC | 2009 | 11 |
| 0 (this device) | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants… | Implant Direct Sybron Manufacturing, LLC | 2020 | — |
| +1 | K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | 2025 | — |
| +2 | K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | 2026 | — |
| +1 | K252145 | GEN5™ and GEN5+™ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K090234 | Spectra System Dental Implants 2008Summary page 4…roduct Code: NHA Predicate Device: Implant Direct LLC’s Spectra-System Dental Implants 2008 (now Legacy3 Dental Implant) (K090234) Reference Devices: Implant Direct LLC’s Legacy3 Implants (6mm Length) (K131097); Implan… | 2009 |
| † | K131097 | LEGACY3 6MM Length Implants | 2013 |
| † | K060063 | Legacy Abutment System | 2006 |
| † | K192218 | Custom Legacy and Custom InterActive Titanium Abutments | 2020 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2021 | Class II | Z-0198-2022 | Packaging change control | Packaged dental implant contains a different size then the size declared on the labeling. |
| Sep 23, 2021 | Class II | Z-0197-2022 | Packaging change control | Packaged dental implant contains a different size then the size declared on the labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 19 ancestors have a recall of any class.
- Of its descendants, K251938 (Paragon Implant Mfg., LLC, 2025) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K090234.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and…
Read the full statement (237 words)
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
• Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.
• Short (<10mm) 3.7mm implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.
The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy2, Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment. As an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
• Fixture-mounts as an abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
• Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 implants are compatible with the following abutments.
Manufacturer Abutment Line Platform Diameter
Implant Direct Legacy 3.0mm, 3.5mm, 4.5mm, 5.7mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192221: Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192221
Report an extraction error
Are you the manufacturer?
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