# K111889: Zimmer Dental Tapered Screw-Vent M Implant

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Dec 6, 2011 after 158 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices 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 Screw-Vent® T Implant: named in the summary without a submission number
- (no number) Tapered Screw-Vent® Implant System: named in the summary without a submission number

## Most influential descendants
- K133339: Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M Implant, HA Coated (2014), 3 descendants of its own
- K143051: ArgenIS Titanium Abutments (2015), 2 descendants of its own
- K160248: ArgenIS Titanium Abutments (2016), 1 descendant of its own
- K243731: HEXIM Implant; Samwon General Abutments (2025), 0 descendants of its own
- K172430: ArgenIS Titanium Abutments (2018), 0 descendants of its own

## Recalls of this device
- May 10, 2018 · Class II · Z-2963-2018: Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.

## Indications for use
The Tapered Screw-Vent® M 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/K111889
Methodology: https://510kreport.com/methodology