510(k) · Cleared
ClearedLEGACY3 6MM Length Implants
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 Aug 22, 2013 as substantially equivalent to K061319 (Implant Direct, LLC, 2006) and 6 other predicates after a 126-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Aug 22, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K894595 (1990). 26 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK131097 LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC · 2013
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) | K131097 | LEGACY3 6MM Length Implants | Implant Direct Sybron Manufacturing, LLC | 2013 | — |
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 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 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? (7)
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 |
|---|---|---|---|
| * | K061319 | Spectra SystemSummary page 1…Implant Regulation Number: 872.3640 Product Codes: DZE Regulatory Class: 11 3. Predicate Device(s): Spectra Dental Implant System (K061 319) Implant Direct Legacy Dental Implants with HA Coating (K073033) Implant Direct Spectra-System Implants 2008 (K09… | 2006 |
| * | K073033 | Legacy Dental ImplantsSummary page 1…Regulatory Class: 11 3. Predicate Device(s): Spectra Dental Implant System (K061 319) Implant Direct Legacy Dental Implants with HA Coating (K073033) Implant Direct Spectra-System Implants 2008 (K090234) Implant Direct SwissPlant Implants (K081 396) Bico… | 2007 |
| * | K090234 | Spectra System Dental Implants 2008Summary page 1…Spectra Dental Implant System (K061 319) Implant Direct Legacy Dental Implants with HA Coating (K073033) Implant Direct Spectra-System Implants 2008 (K090234) Implant Direct SwissPlant Implants (K081 396) Bicon Implants with a 2.5mm Internal Connection (K092035)… | 2009 |
| * | K081396 | Swissplant Dental Implant SystemSummary page 1…Implant Direct Legacy Dental Implants with HA Coating (K073033) Implant Direct Spectra-System Implants 2008 (K090234) Implant Direct SwissPlant Implants (K081 396) Bicon Implants with a 2.5mm Internal Connection (K092035) The Bicon 5.0 X 5.0mm and 6.0 X 5.0mm Dental Implant (… | 2009 |
| * | K092035 | Bicon Implants with a 2.5MM Internal ConnectionSummary page 1…Implant Direct Spectra-System Implants 2008 (K090234) Implant Direct SwissPlant Implants (K081 396) Bicon Implants with a 2.5mm Internal Connection (K092035) The Bicon 5.0 X 5.0mm and 6.0 X 5.0mm Dental Implant (K073368) IT[ Dental Implant System (K030007) 4. Dev… | 2009 |
| * | K073368 | 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental ImplantSummary page 1…ant Direct SwissPlant Implants (K081 396) Bicon Implants with a 2.5mm Internal Connection (K092035) The Bicon 5.0 X 5.0mm and 6.0 X 5.0mm Dental Implant (K073368) IT[ Dental Implant System (K030007) 4. Device Description: The Legacy3 6mm length implants consists of t… | 2008 |
| * | K030007 | Iti Dental Implant SystemSummary page 1…Bicon Implants with a 2.5mm Internal Connection (K092035) The Bicon 5.0 X 5.0mm and 6.0 X 5.0mm Dental Implant (K073368) IT[ Dental Implant System (K030007) 4. Device Description: The Legacy3 6mm length implants consists of two-piece implants for one-stage or t… | 2003 |
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 6 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 26 ancestors have a recall of any class.
- 15 other devices also cite its predicate K061319.
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?
Legacy3 6mm Length implants consist of 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131097 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131097: LEGACY3 6MM Length Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131097
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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