# K191458: Legacy SMARTBase Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Oct 10, 2019 after 132 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: 12 generations back to K894595 (1990). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181359: InterActive SMARTBase Abutments, Implant Direct Sybron Manufacturing, LLC (2018) Summary page 4.

## Most influential descendants
- K223535: SMARTbase Abutment System (2023), 0 descendants of its own

## Indications for use
The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations. The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTBase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment. x Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. x Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors. Compatibility Legacy SMARTBase engaging abutments are compatible at the implant level with Legacy (3.0mm, 3.5mm, 4.5mm and 5.7mm platform diameter) 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, 10mm, 5.7mm 11.5mm, 13mm, Legacy2, 3, 4, simplyLegacy2, 3.2mm, 3.7mm, 4.2mm, 4.7mm, 3.0mm, 3.5mm, 16mm simplyLegacy3 5.2mm, 5.7mm, 7.0mm 4.5mm, 5.7mm

Source page: https://510kreport.com/device/K191458
Methodology: https://510kreport.com/methodology