# K192218: Custom Legacy and Custom InterActive Titanium Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: May 8, 2020 after 267 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: 2 generations back to K011028 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060063: Legacy Abutment System, Implant Direct, LLC (2006) Summary page 4.

## Indications for use
Custom Titanium Abutments are customizable devices 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. • Custom Titanium Abutment for narrow (3.2mmD, 3.3mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements. • Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors. Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy1, Legacy2, Legacy3, Legacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants. Implant Line Body Diameter Platform Diameter Implant Length Legacy1 3.7mm, 4.2mm, 4.7mm, 5.7mm 3.5mm, 4.5mm, 8mm to 16mm 5.7mm Legacy2, Legacy3, Legacy4, 3.2mm, 3.7mm, 4.2mm, 3.0mm, 3.5mm, simplyLegacy2, simplyLegacy3 4.7mm, 5.2mm, 5.7mm, 7.0mm 4.5mm, 5.7mm Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants. Implant Line Body Diameter Platform Diameter Implant Length InterActive, simplyInterActive 3.2mm, 3.7mm, 4.3mm, 5.0mm 3.0mm, 3.4mm 8mm to16mm SwishActive 3.3mm, 4.1mm, 4.8mm 3.0mm, 3.4mm 8mm to16mm

Source page: https://510kreport.com/device/K192218
Methodology: https://510kreport.com/methodology