# K082639: Zimmer Dental Tapered Swissplus Implants

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Dec 19, 2008 after 100 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Tapered SwissPlus® MTX Surface Implant: named in the summary without a submission number
- (no number) Tapered Screw-Vent® Implant: named in the summary without a submission number

## Recalls of this device
- Mar 20, 2017 · Class II · Z-1823-2017: It was manufactured with the minor diameter of the internal thread that is below specification.

## Indications for use
The Tapered SwissPlus ® Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Source page: https://510kreport.com/device/K082639
Methodology: https://510kreport.com/methodology