# K060063: Legacy Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct, LLC
- Decided: May 19, 2006 after 130 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011028 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001) Summary page 1.

## Most influential descendants
- K192218: Custom Legacy and Custom InterActive Titanium Abutments (2020), 0 descendants of its own

## Indications for use
The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients. The Legacy Abutment System is compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual. Implant Direct LLC will monitor the compatible implants for modifications to ensure future compatibility. In the event of any modification, Implant Direct LLC will either modify the Legacy abutment to ensure compatibility, or cease claiming compatibility to the modified Zimmer Dental Screw-Vent implants.

Source page: https://510kreport.com/device/K060063
Methodology: https://510kreport.com/methodology