# K211872: PiezoImplant System

- Pathway: 510(k) (Traditional)
- Applicant: Rex Implants, Inc.
- Decided: Oct 12, 2022 after 482 days
- Product code: NRQ (Blade-Form Endosseous Dental Implant)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K925765 (1993). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133049: 3I T3(R) External Hex Dental Implants, Biomet 3i (2014) Summary page 4.

## Indications for use
The Piezolmplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate adult patients over the age of 21 in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The Piezolmplant System is intended for delayed loading.

Source page: https://510kreport.com/device/K211872
Methodology: https://510kreport.com/methodology