# K192221: Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Jun 25, 2020 after 315 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894595 (1990). 19 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090234: Spectra System Dental Implants 2008, Implant Direct, LLC (2009) Summary page 4.

## Most influential descendants
- K251938: GEN5 and GEN5+ Dental Implant System (2025), 1 descendant of its own
- K261392: TriActive Dental Implant System (2026), 0 descendants of its own
- K252145: GEN5™ and GEN5+™ 3.3mmD Dental Implants (2025), 0 descendants of its own

## Recalls of this device
- Sep 23, 2021 · Class II · Z-0198-2022: Packaged dental implant contains a different size then the size declared on the labeling.
- Sep 23, 2021 · Class II · Z-0197-2022: Packaged dental implant contains a different size then the size declared on the labeling.

## Indications for use
Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are 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. • Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization. • Short (<10mm) 3.7mm implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy2, Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment. As an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. • Fixture-mounts as an abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. • Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors. Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 implants are compatible with the following abutments. Manufacturer Abutment Line Platform Diameter Implant Direct Legacy 3.0mm, 3.5mm, 4.5mm, 5.7mm

Source page: https://510kreport.com/device/K192221
Methodology: https://510kreport.com/methodology