# K011028: Screw-Vent Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Dental, Inc.
- Decided: May 21, 2001 after 46 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
No predicates in its family tree.
184 later devices descend from it; 16 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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
- K191986: DESS Dental Smart Solutions (2019), 38 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."

Source page: https://510kreport.com/device/K011028
Methodology: https://510kreport.com/methodology