# K150388: Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Bio Concept Co., Ltd.
- Decided: Nov 12, 2015 after 267 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- 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: 11 generations back to K894595 (1990). 70 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123784: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 5.

## Most influential descendants
- K212364: BLT Dental Implant System (2022), 0 descendants of its own

## Indications for use
Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient’s chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

Source page: https://510kreport.com/device/K150388
Methodology: https://510kreport.com/methodology