# K974106: Icon Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Bio Science Technologies, Inc.
- Decided: Jun 1, 1998 after 213 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: 1 generation back to K945398 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945398: Branemark System (R) Mkii Self-Tapping Fixture, Nobelpharma USA, Inc. (1995) Summary page 1.

## Indications for use
The Bio Science Technologies, Inc.’s Icon Implant System consists of a screw implant and a cover screw which are contained within a titanium (CP) canister. An actual implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc. The Icon Implant System is intended for use in either partially or fully edentulous mandibles and maxillae in the following areas: . Support of fixed (cemented) restorations utilizing multiple abutments; . Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments; e Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona, or hader bar; Terminal or intermediate abutment support for fixed bridgework; Free standing restorations without involvement of adjacent dentition when the external hex is engaged.

Source page: https://510kreport.com/device/K974106
Methodology: https://510kreport.com/methodology