# K090234: Spectra System Dental Implants 2008

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct, LLC
- Decided: May 15, 2009 after 105 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894595 (1990). 18 ancestors in all.
22 later devices descend from it; 8 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061319: Spectra System, Implant Direct, LLC (2006)
- K080713: Reactive Dental Implant System, Implant Direct, LLC (2008)
- K073033: Legacy Dental Implants, Implant Direct, LLC (2007) Summary page 1.

## Most influential descendants
- K130572: Interactive/ SWISHPLUS2 Implant System (2013), 10 descendants of its own
- K143011: 2014 InterActive/SwishActive System (2015), 8 descendants of its own
- K181359: InterActive SMARTBase Abutments (2018), 6 descendants of its own
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K192221: Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts (2020), 3 descendants of its own

## Recalls of this device
- Oct 11, 2019 · Class II · Z-1157-2020: 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 
- Oct 7, 2019 · Class II · Z-1041-2020: Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
- Aug 9, 2019 · Class II · Z-0364-2020: 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: 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: 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: 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. A
- Jul 21, 2017 · Class II · Z-0007-2018: 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: 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 possi
- Nov 28, 2016 · Class II · Z-0961-2017: 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: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K090234
Methodology: https://510kreport.com/methodology