# K060291: Preformance Temporary Cylinder

- Pathway: 510(k) (Special)
- Applicant: Implant Innovations, Inc.
- Decided: Feb 27, 2006 after 21 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871954 (1987). 3 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053170: Preformance Posts, Implant Innovations, Inc. (2006) Summary page 1.

## Most influential descendants
- K122988: Klockner Dental Implant Abutments (2013), 9 descendants of its own
- K151194: Klockner Dental Implant Abutments (II) (2016), 4 descendants of its own
- K160221: Implance Dental Implant System, Implance Dental Abutment System (2016), 3 descendants of its own
- K160850: Nucleoss Tpure Implant System (2017), 2 descendants of its own
- K181266: Implantswiss Dental Implant System, Implantswiss Dental Abutment System (2018), 1 descendant of its own

## Recalls of this device
- Nov 25, 2015 · Class II · Z-2493-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2415-2016: Pouches may not have been sealed during packing.
- Oct 8, 2007 · Not classified · Z-0128-2008: Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant p

## Indications for use
The PreFormance Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.

Source page: https://510kreport.com/device/K060291
Methodology: https://510kreport.com/methodology