# K171409: OT Equator

- Pathway: 510(k) (Traditional)
- Applicant: Rhein'83 Srl
- Decided: Apr 9, 2018 after 329 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: 2 generations back to K950260 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142211: OT Equator, Rhein'83 Srl (2015) Summary page 7.

## Indications for use
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla. The OT Equator abutments are indicated for use with the following implant systems:

Source page: https://510kreport.com/device/K171409
Methodology: https://510kreport.com/methodology