# K061969: Preformance Posts and Temporary Cylinders

- Pathway: 510(k) (Special)
- Applicant: Implant Innovations, Inc.
- Decided: Jul 21, 2006 after 9 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K871954 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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.
- K060291: Preformance Temporary Cylinder, Implant Innovations, Inc. (2006) Summary page 1.

## Most influential descendants
- K102467: Uta and Uha (2011), 0 descendants of its own

## Recalls of this device
- Nov 25, 2015 · Class II · Z-2436-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2437-2016: Pouches may not have been sealed during packing.

## Indications for use
The PreFormance Abutment Posts and 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/K061969
Methodology: https://510kreport.com/methodology