# K130572: Interactive/ SWISHPLUS2 Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Dec 24, 2013 after 295 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894595 (1990). 40 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 1.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 1.
- K090234: Spectra System Dental Implants 2008, Implant Direct, LLC (2009) Summary page 1.
- K081101: Spectra-System Abutments 2008, Implant Direct, LLC (2009) Summary page 1.
- K081396: Swissplant Dental Implant System, Implant Direct, LLC (2009) Summary page 1.
- K061319: Spectra System, Implant Direct, LLC (2006) Summary page 1.
- K092035: Bicon Implants with a 2.5MM Internal Connection, Bicon, LLC (2009) Summary page 1.
- K073368: 5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant, Bicon, LLC (2008) Summary page 1.
- K030007: Iti Dental Implant System, Straumann USA (2003) Summary page 1.

## Most influential descendants
- 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
- K230873: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (2023), 0 descendants of its own

## Recalls of this device
- Oct 26, 2018 · Class II · Z-0363-2020: packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
- Mar 14, 2018 · Class II · Z-1917-2018: The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
- Jan 23, 2018 · Class II · Z-0539-2018: InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
- Mar 3, 2017 · Class II · Z-2551-2018: The main vial label lists the incorrect part number, but the cap label is correct.

## Indications for use
lnterActive/SwishPlus2 Implant System consists of twa-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. Also indicated for multiple tooth.replacements or denture stabilization. Compatibility: InterActive and SwishPlus2 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 NobelActiveml RP (Regular Platform - 3.4mm diameter) abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection.NobelActive M NP (Narrow Platform- 3.0mm diameter) and Nobe[Active h RP (Regular Platform - 3.4mm diameter) (3.5-5.OmmD, 8.5-1 SmmLength) implants.

Source page: https://510kreport.com/device/K130572
Methodology: https://510kreport.com/methodology