# K142211: OT Equator

- Pathway: 510(k) (Traditional)
- Applicant: Rhein'83 Srl
- Decided: Nov 25, 2015 after 470 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: 1 generation back to K950260 (1997). 2 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033630: Modification of: Sphero Flex, Pivot Flex, and Sphero Block, Rhein 83 Srl (2004) Summary page 5.
- K950260: Quick Coupling Device for Dental Prostheses, Dr. Joseph E. Grasso, D.D.S. (1997) Summary page 5.

## Most influential descendants
- K163060: Deep Conical (DC) Implants and Accessories (2017), 7 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K180465: Provata Implant System (2018), 2 descendants of its own
- K171694: s-Clean TiN Coating Abutments (2017), 2 descendants of its own
- K254145: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (2026), 0 descendants of its own

## 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 implant systems listed in Attachment B.

Source page: https://510kreport.com/device/K142211
Methodology: https://510kreport.com/methodology