# K143011: 2014 InterActive/SwishActive System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Jul 16, 2015 after 269 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894595 (1990). 41 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130572: Interactive/ SWISHPLUS2 Implant System, Implant Direct Sybron Manufacturing, LLC (2013) Summary page 4.

## Most influential descendants
- K181359: InterActive SMARTBase Abutments (2018), 6 descendants of its own
- 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

## 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 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 Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. These implants are also indicated for multiple tooth replacements or denture stabilization. Compatibility: InterActive and SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform – 3.0mm diameter) and NobelActive™ RP (Regular Platform – 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform– 3.0mm diameter) and NobelActive™ RP (Regular Platform – 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.

Source page: https://510kreport.com/device/K143011
Methodology: https://510kreport.com/methodology