# K013227: Screw Vent Implant; Tapered Screw Vent Implant

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Dental, Inc.
- Decided: Nov 19, 2001 after 53 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894595 (1990). 12 ancestors in all.
305 later devices descend from it; 15 cite it directly.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992937: Dental Implant, Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K993595: Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement), Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K984104: Iti Dental Implant System, Straumann USA (1999) Summary page 1.
- K002374: Iti Dental Implant System Monotype Implant, Straumann USA (2000) Summary page 1.

## Most influential descendants
- K063364: Alpha Bio Dental Implant System (2007), 187 descendants of its own
- K081653: Mdi Mii One-Piece Implant, 2.9MM (2008), 141 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own
- K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant (2006), 122 descendants of its own

## Recalls of this device
- Jul 10, 2017 · Class II · Z-3206-2017: Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supp
- Jul 17, 2014 · Class II · Z-2144-2014: Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

## Indications for use
The ScrewVent and Tapered ScrewVent implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. In patients with an edentulous mandible, ScrewVent and Tapered ScrewVent implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

Source page: https://510kreport.com/device/K013227
Methodology: https://510kreport.com/methodology