# K093749: GC Aadva Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: GC America, Inc.
- Decided: Dec 6, 2010 after 364 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: 8 generations back to K894595 (1990). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072425: Jne Implant System, GC America, Inc. (2008) Summary page 2.
- K971196: Endopore Endosseous Dental Implant System, Innova Corp. (1997) Summary page 2.
- K002513: Astra Tech Implants - Dental System, Astra Tech, Inc. (2001) Summary page 2.
- K033984: Straumann Dental Implant System, Institut Straumann AG (2004) Summary page 2.

## Indications for use
The GC Aadva. Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function. The GC Aadva Implant System is intended for immediate loading only when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K093749
Methodology: https://510kreport.com/methodology