# K921010: Stern Era Alignment Correction Implant Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Apm Stern Gold
- Decided: Sep 1, 1992 after 182 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K130408: Era Micro 23  Female Abutment, Era Micro 30 Female Abutment (2013), 1 descendant of its own
- K193404: UF (II) Bar holder abutment (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K921010
Methodology: https://510kreport.com/methodology