# K023580: Sterngold Acid Etch Dental Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterngold
- Decided: Jan 17, 2003 after 85 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices 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) Implant Innovations Osseotite Dental Implant System: named in the summary without a submission number
- (no number) Nobel Biocare MKIII Dental Implant System: named in the summary without a submission number

## Most influential descendants
- K130408: Era Micro 23  Female Abutment, Era Micro 30 Female Abutment (2013), 1 descendant of its own
- K111798: Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... (2012), 1 descendant of its own
- K193404: UF (II) Bar holder abutment (2020), 0 descendants of its own
- K142667: Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm (2015), 0 descendants of its own

## Indications for use
The Sterngold Acid Etch Dental Implant System consists of endosseous dental implants indicated: For implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis For single tooth or multiple unit prosthesis

Source page: https://510kreport.com/device/K023580
Methodology: https://510kreport.com/methodology