# K020391: Stern Micro Era Attachment System

- Pathway: 510(k) (Special)
- Applicant: Sterngold
- Decided: Mar 8, 2002 after 30 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: 1 generation back to K913348 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913348: The Stern Era System, Sterngold/Implamed (1992) Summary page 1.

## Indications for use
The Stern Micro ERA System is a resilient retention device for dental prosthesis, designed to be used in restoration of removable dentures. Reduced in size by 20% to allow additional space when constructing dental restorations, these attachments maintain the same functionality and ease of use as well as esthetic improvements.

Source page: https://510kreport.com/device/K020391
Methodology: https://510kreport.com/methodology