# K041271: Sterngold 3.25 Era Dental Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterngold
- Decided: Oct 28, 2004 after 169 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. The FDA summary names its predicate without a number.
- (no number) Sterngold ERA Dental Implant System: named in the summary without a submission number
- (no number) Sterngold Narrow Platform Hex Screw Implants: named in the summary without a submission number

## Indications for use
The Sterngold 3.25mm ERA dental implants are intended for permanent as well as temporary surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function. Immediate loading of the ERA Implant should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone and where occlusal and lateral forces can be limited with appropriate occlusal design and a soft diet.

Source page: https://510kreport.com/device/K041271
Methodology: https://510kreport.com/methodology