# K113753: Zimmer Dental Tapered Screw-Vent X

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Aug 30, 2012 after 253 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: 9 generations back to K894595 (1990). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101880: Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant, Zimmer Dental, Inc. (2010) Summary page 1.
- K011028: Screw-Vent Dental Implant System, Sulzer Dental, Inc. (2001) Summary page 1.
- K953101: Paragon Implant System, Core-Vent Bio-Engineering, Inc. (1995) Summary page 1.
- K013227: Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. (2001) Summary page 1.
- K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 1.
- K072589: Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11, H13 and H16, Zimmer Dental, Inc. (2007) Summary page 1.

## Most influential descendants
- K132258: Zimmer Dental Trabecular Metal Implant System (2013), 0 descendants of its own

## Indications for use
The Tapered Screw-Vent® X 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. The 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.

Source page: https://510kreport.com/device/K113753
Methodology: https://510kreport.com/methodology