# K142667: Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterngold Dental, LLC
- Decided: Jan 7, 2015 after 110 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: 4 generations back to K894844 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023580: Sterngold Acid Etch Dental Implant System, Sterngold (2003) Summary page 4.
- 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 ..., Sterngold Dental, LLC (2012) Summary page 4.

## Indications for use
The Stern AC Dental Implant System can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable abutments and Stern IC Solid Abutments. The Stern AC Dental Implant System is only intended for use with straight abutments.

Source page: https://510kreport.com/device/K142667
Methodology: https://510kreport.com/methodology