510(k) · Cleared
Recalled · Class II · 2019Spectra System Dental Implants 2008
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Direct, LLC · DZE Implant, Endosseous, Root-Form
Cleared on May 15, 2009 as substantially equivalent to K061319 (Implant Direct, LLC, 2006) and 2 other predicates after a 105-day review. Its family tree reaches back 6 generations to 1990. 22 later devices descend from it. It has been recalled 11 times.
- Decided
- May 15, 2009
- Review
- 105 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 11
- Predicates
- 3
Its longest line of descent runs back 6 generations to K894595 (1990). 18 ancestors in all. 22 later devices descend from it, 8 citing it directly.
- Root · 6 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 4 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 3 generations backK013227 Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 2001 · Recalled
- 2 generations backK073161 Replus Dental Implants (HA)Implant Direct, LLC · 2008
- 1 generation backK080713 Reactive Dental Implant SystemImplant Direct, LLC · 2008
- This deviceK090234 Spectra System Dental Implants 2008Implant Direct, LLC · 2009
- Descendant · cites it directly · 10 of its ownK130572 Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · Recalled
- Descendant · 2 generations on · 8 of its ownK143011 2014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015
- Descendant · 3 generations on · 6 of its ownK181359 InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018
- Descendant · 4 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK192221 Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental…Implant Direct Sybron Manufacturing, LLC · 2020 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC · 2013 · cites it directly10descendants
- K1430112014 InterActive/SwishActive SystemImplant Direct Sybron Manufacturing, LLC · 2015 · 2 generations on8descendants
- K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC · 2018 · 3 generations on6descendants
- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 4 generations on3descendants
- K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Implant Direct Sybron Manufacturing, LLC · 2020 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −5 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −4 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −3 | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | Sulzer Dental, Inc. | 2001 | 2 |
| −2 | K073161 | Replus Dental Implants (HA) | Implant Direct, LLC | 2008 | — |
| −1 | K080713 | Reactive Dental Implant System | Implant Direct, LLC | 2008 | — |
| 0 (this device) | K090234 | Spectra System Dental Implants 2008 | Implant Direct, LLC | 2009 | — |
| +1 | K130572 | Interactive/ SWISHPLUS2 Implant System | Implant Direct Sybron Manufacturing, LLC | 2013 | 4 |
| +2 | K143011 | 2014 InterActive/SwishActive System | Implant Direct Sybron Manufacturing, LLC | 2015 | — |
| +3 | K181359 | InterActive SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | 2018 | — |
| +4 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +1 | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants… | Implant Direct Sybron Manufacturing, LLC | 2020 | 2 |
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 |
|---|---|---|
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K061319 | Spectra System | 2006 |
| * | K080713 | Reactive Dental Implant System | 2008 |
| * | K073033 | Legacy Dental ImplantsSummary page 1…: Implant Direct LLC Spectra-System (KO61319), Implant Direct LLC ReActive Dental Implant System (KO80713), Implant Direct LLC Legacy Implants With HA Coating (K073033) 4. Device Description: The Spectra-System Dental Implants 2008 system consists of implants, abutments, healing comp… | 2007 |
What descends from it? (22)
See all 228 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130572 | Interactive/ SWISHPLUS2 Implant System | 2013 | 10 |
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2… | 2020 | 3 |
| K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | 2017 | 2 |
| K250476 | NizPlant Dental Implant System | 2025 | 0 |
| K183044 | JTK Dental Implant System | 2020 | 0 |
| K153509 | GPS Angled Abutment | 2016 | 0 |
| K131097 | LEGACY3 6MM Length Implants | 2013 | 0 |
| K122559 | Biodenta Dental Implant System - Abutments | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2019 | Class II | Z-1157-2020 | Mixed-up of materials/components | Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to… |
| Oct 7, 2019 | Class II | Z-1041-2020 | Packaging process control | Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. |
| Aug 9, 2019 | Class II | Z-0364-2020 | Packaging | A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered. |
| Aug 8, 2018 | Class II | Z-0018-2020 | Employee error | Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number. |
| Jan 19, 2018 | Class II | Z-1167-2018 | Process control | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer). |
| Oct 10, 2017 | Class II | Z-0185-2018 | Process design | One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not… |
| Jul 21, 2017 | Class II | Z-0007-2018 | Employee error | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. |
| Dec 12, 2016 | Class II | Z-1112-2017 | Packaging process control | The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating… |
| Nov 28, 2016 | Class II | Z-0961-2017 | Labeling mix-ups | Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top. |
| Nov 15, 2016 | Class II | Z-1920-2018 | Labeling mix-ups | The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled. |
| Mar 4, 2016 | Class II | Z-1267-2016 | Nonconforming Material/Component | Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K130572 (Implant Direct Sybron Manufacturing, LLC, 2013) has gone furthest, with 10 descendants of its own.
- 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. 2009, 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?
Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth or multiple-tooth restorations, recognizing bone stability and appropriate occusal load requirements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090234 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090234: Spectra System Dental Implants 2008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090234
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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