# K133791: Ora 0.4MM [S], Ora 1.0MM [S], Ora 2.0MM [S], Ora 3.0MM [S], Ora 4.0MM [S]

- Pathway: 510(k) (Abbreviated)
- Applicant: Sterngold Dental, LLC
- Decided: Apr 16, 2014 after 124 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K083876 (2010). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900099: The O-Ring System - Ors, Attachments Intl., Inc. (1991) Summary page 1.
- K130183: Sfi Bar Abutments, Sterngold Dental, LLC (2013) Summary page 1.
- K132814: Sfi-Bar Implant Abutments, Sterngold Dental, LLC (2014). Cleared while this submission was under review Summary page 1.

## Indications for use
The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SF1 Abutments which are screwed into endosseous implants.

Source page: https://510kreport.com/device/K133791
Methodology: https://510kreport.com/methodology