# K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Sep 8, 2006 after 109 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
Longest line of descent: 6 generations back to K894595 (1990). 26 ancestors in all.
122 later devices descend from it; 13 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013227: Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. (2001) Summary page 2.
- K950577: Swede-Vent Implant, Core-Vent Corp. (1995) Summary page 2.
- K011245: Advent Implant System, Swiss Plus Implant System, Sulzer Dental, Inc. (2001). Our reading of the summary gave K001245, FDA’s number for 3T L. V. Control Valve (3t Medical Systems, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zimmer Dental AdVent Implants”.
- K002614: Advent Implant System, Core-Vent Corp. (2000) Summary page 2.
- K052997: Zimmer Dental One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 2.
- K050705: Tiunite Implants, Nobel Biocare AB (2005) Summary page 2.

## Most influential descendants
- K072589: Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11, H13 and H16 (2007), 98 descendants of its own
- K101880: Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant (2010), 94 descendants of its own
- K112160: Tapered Screw-Vent X Implant (2011), 88 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own

## Recalls of this device
- Nov 6, 2009 · Not classified · Z-0499-2010: The devices may not meet specifications, which may result in fracturing during tightening of the component.

## Indications for use
The Tapered Screw-Vent®, Screw-Vent®, AdVent, and Zimmer®One-Piece 3.7 mm Dental 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. Zimmer One-Piece 3.7 mm implants are limited to restorations (immediately loaded or loaded after a conventional healing period) in the premolar, cuspid, and incisor regions of partially edentulous jaws.

Source page: https://510kreport.com/device/K061410
Methodology: https://510kreport.com/methodology