# K060376: Simpler HA Threaded, ST 5002-8, Sit 5002-8, ST 5011-ST5014, ST 5021-24

- Pathway: 510(k) (Special)
- Applicant: Simpler Implant, Inc.
- Decided: Apr 25, 2006 after 70 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 Simpler HA Coated Threaded Dental Implants are endosseous threaded implants used as an artificial root structure to replace missing teeth. They are used to support crowns, bridges, or dentures in the maxilla or mandible area of the mouth.

Source page: https://510kreport.com/device/K060376
Methodology: https://510kreport.com/methodology