# K181359: InterActive SMARTBase Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Aug 15, 2018 after 85 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: 11 generations back to K894595 (1990). 42 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143011: 2014 InterActive/SwishActive System, Implant Direct Sybron Manufacturing, LLC (2015) Summary page 4.

## Most influential descendants
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K191458: Legacy SMARTBase Abutments (2019), 1 descendant of its own
- K230873: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (2023), 0 descendants of its own
- K223535: SMARTbase Abutment System (2023), 0 descendants of its own
- K222469: TIB Abutments (2023), 0 descendants of its own

## Indications for use
InterActive/SwishActive Implant System consists of 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 SMARTBase support for fixed bridgework. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The SMARTBase Abutments consist of two major parts. Specifically, the titanium base and zirconia top components make up a two-piece abutment. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. ● Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization. Compatibility: InterActive SMARTBase abutments are compatible at the implant level with InterActive (3.0mm and 3.4mm Platform) and SwishActive (3.0mm and 3.4mm Platform) system implants. Manufacturer Implant Line Body Diameter Implant Platform Implant Direct InterActive 3.2mm, 3.7mm, 4.3mm, 5.0mm 3.0mm, 3.4mm Implant Direct SwishActive 3.3mm, 4.1mm, 4.8mm 3.0mm, 3.4mm

Source page: https://510kreport.com/device/K181359
Methodology: https://510kreport.com/methodology