# K081396: Swissplant Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct, LLC
- Decided: Jan 14, 2009 after 240 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011245 (2001). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011245: Advent Implant System, Swiss Plus Implant System, Sulzer Dental, Inc. (2001)

## Most influential descendants
- K130572: Interactive/ SWISHPLUS2 Implant System (2013), 10 descendants of its own
- K143011: 2014 InterActive/SwishActive System (2015), 8 descendants of its own
- 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

## Recalls of this device
- Jan 9, 2019 · Class II · Z-1126-2020: Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer 
- Jan 19, 2018 · Class II · Z-1168-2018: The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
- Oct 28, 2015 · Class II · Z-0396-2016: Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.

## Indications for use
The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.

Source page: https://510kreport.com/device/K081396
Methodology: https://510kreport.com/methodology