# K112160: Tapered Screw-Vent X Implant

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Dec 14, 2011 after 140 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 19 (0 Class I)
- 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.
88 later devices descend from it; 3 cite it directly.
0 of 124 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
- 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
- K183518: Preat Abutments (2019), 22 descendants of its own
- K212628: DESS Dental Smart Solutions (2022), 20 descendants of its own

## Recalls of this device
- Jan 6, 2016 · Class II · Z-0775-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0772-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0774-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0783-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0784-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0773-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0780-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0776-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0777-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0778-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0779-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0781-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Jan 6, 2016 · Class II · Z-0782-2016: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precaution
- Mar 22, 2012 · Not classified · Z-1511-2012: This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implan
- Mar 22, 2012 · Not classified · Z-1510-2012: This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implan
- Mar 22, 2012 · Not classified · Z-1514-2012: This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implan
- Mar 22, 2012 · Not classified · Z-1512-2012: This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implan
- Mar 22, 2012 · Not classified · Z-1515-2012: This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implan
- Mar 22, 2012 · Not classified · Z-1513-2012: This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implan

## 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/K112160
Methodology: https://510kreport.com/methodology