510(k) · Cleared
Recalled · Class II · 2018Spectra System
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 Sep 29, 2006 after a 141-day review. The FDA summary names no predicate by number. 67 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 29, 2006
- Review
- 141 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 4
- Predicates
- 0
67 later devices descend from it, 16 citing it directly.
- This deviceK061319 Spectra SystemImplant Direct, LLC · 2006
- Descendant · cites it directly · 43 of its ownK073161 Replus Dental Implants (HA)Implant Direct, LLC · 2008
- Descendant · cites it directly · 25 of its ownK073033 Legacy Dental ImplantsImplant Direct, LLC · 2007
- Descendant · cites it directly · 23 of its ownK080713 Reactive Dental Implant SystemImplant Direct, LLC · 2008
- Descendant · cites it directly · 22 of its ownK090234 Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · Recalled
- Descendant · 2 generations on · 18 of its ownK101225 Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001…Promimic AB · 2011
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K073161Replus Dental Implants (HA)Implant Direct, LLC · 2008 · cites it directly43descendants
- K073033Legacy Dental ImplantsImplant Direct, LLC · 2007 · cites it directly25descendants
- K080713Reactive Dental Implant SystemImplant Direct, LLC · 2008 · cites it directly23descendants
- K090234Spectra System Dental Implants 2008Implant Direct, LLC · 2009 · cites it directly22descendants
- K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB · 2011 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061319 | Spectra System | Implant Direct, LLC | 2006 | — |
| +1 | K073161 | Replus Dental Implants (HA) | Implant Direct, LLC | 2008 | — |
| +1 | K073033 | Legacy Dental Implants | Implant Direct, LLC | 2007 | — |
| +1 | K080713 | Reactive Dental Implant System | Implant Direct, LLC | 2008 | — |
| +1 | K090234 | Spectra System Dental Implants 2008 | Implant Direct, LLC | 2009 | 11 |
| +2 | K101225 | Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental… | Promimic AB | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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?
The FDA summary names no predicate by number.
What descends from it? (67)
See all 6716 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073161 | Replus Dental Implants (HA) | 2008 | 43 |
| K073033 | Legacy Dental Implants | 2007 | 25 |
| K080713 | Reactive Dental Implant System | 2008 | 23 |
| K090234 | Spectra System Dental Implants 2008 | 2009 | 22 |
| K070905 | Endosseous Dental Implant System | 2007 | 17 |
| K081101 | Spectra-System Abutments 2008 | 2009 | 11 |
| K130572 | Interactive/ SWISHPLUS2 Implant System | 2013 | 10 |
| K133050 | One Plus Implant System | 2014 | 1 |
| K131701 | Z5MLB, Z5MLC | 2013 | 1 |
| K110337 | Universal Maxillary Molar | 2012 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2018 | Class II | Z-0010-2020 | Employee error | The incorrect device was packaged in the vial. |
| May 18, 2018 | Class II | Z-2376-2018 | Process control | Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant |
| May 2, 2017 | Class II | Z-2125-2017 | Nonconforming Material/Component | Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification. |
| Jul 5, 2016 | Class II | Z-2320-2016 | Process control | Issue with design specification; oversized condition. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K073161 (Implant Direct, LLC, 2008) has gone furthest, with 43 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.
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 Spectra Dental Implant System consists of one-piece or two-piece implants for single-stage or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established. The ScrewDirect 3.0rmm implant is…
Read the full statement (209 words)
The Spectra Dental Implant System consists of one-piece or two-piece implants for single-stage or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.
The ScrewDirect 3.0rmm implant is indicated for:
1. An artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
2. Multiple tooth replacements or denture stabilization.
The Screw Redirect implant is intended for support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of the partially edentulous maxillary jaw. It is indicated for immediate functional loading when four or more implants are splinted together in the endentulous upper or lower jaw.
The Screw Indirect implant is indicated for the support and retention of bar overdentures or as a terminal or intermediary attachment for screw-retained fixed bridgework. It is indicated for immediate functional loading when four or more implants are splinted together in the edentulous upper or lower jaw. This implant model is not indicated for use with abutments, only with a 2mm extender.
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/K061319 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061319: Spectra System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061319
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