# K100411: Various Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Grundy Advanced Biomedical Systems, LLC
- Decided: Jul 28, 2010 after 162 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
THE IMPLANT(S) IS DESIGNED FOR USE IN THE EDENTULOUS SITES IN THE MANDIBLE OR MAXILLA FOR SUPPORT OF A COMPLETE DENTURE PROSTHESIS, A TERMINAL OR INTERMEDIATE ABUTMENT FOR FIXED OR PARTIAL DENTURES, OR A SINGLE TOOTH REPLACEMENT. THE 8,25MM LONG IMPLANT CAN NOT BE USED AS A SINGLE TOOTH REPLACEMENT.

Source page: https://510kreport.com/device/K100411
Methodology: https://510kreport.com/methodology