# K101977: Tapered Screw-Vent T Implant

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Sep 14, 2010 after 62 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) Zimmer Dental Tapered Screw-Vent® Implant System: named in the summary without a submission number
- (no number) NobelReplace Tapered Conical Connection: 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
- K172430: ArgenIS Titanium Abutments (2018), 0 descendants of its own
- K142082: Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour Abutement (2014), 0 descendants of its own

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1189-2018: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
- Nov 20, 2017 · Class II · Z-0284-2018: Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
- Jun 25, 2014 · Class II · Z-2050-2014: Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.

## Indications for use
The Tapered Screw-Vent® T 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/K101977
Methodology: https://510kreport.com/methodology