# K061319: Spectra System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct, LLC
- Decided: Sep 29, 2006 after 141 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
67 later devices descend from it; 16 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K073161: Replus Dental Implants (HA) (2008), 43 descendants of its own
- K073033: Legacy Dental Implants (2007), 25 descendants of its own
- K080713: Reactive Dental Implant System (2008), 23 descendants of its own
- K090234: Spectra System Dental Implants 2008 (2009), 22 descendants of its own
- K101225: Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1 (2011), 18 descendants of its own

## Recalls of this device
- Aug 7, 2018 · Class II · Z-0010-2020: The incorrect device was packaged in the vial.
- May 18, 2018 · Class II · Z-2376-2018: 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: 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: Issue with design specification; oversized condition.

## Indications for use
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.

Source page: https://510kreport.com/device/K061319
Methodology: https://510kreport.com/methodology