# K160382: OT Equator

- Pathway: 510(k) (Traditional)
- Applicant: Rhein'83 Srl
- Decided: Aug 11, 2016 after 183 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 5.

## 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: NOBEL BIOCARE AB - NobelActive NP 3.5 NOBEL BIOCARE AB - NobelActive RP 4,3 - 5 NOBEL BIOCARE USA LLC - Replace Select TC NP 3.5 NOBEL BIOCARE USA INC - Replace Select Straight TiUnit RP 4.3 NOBEL BIOCARE USA LLC - Replace Select Straight TiUnit WP 5 NOBEL BIOCARE AB - Brénemark System Mk III TiUnite NP 3.3 NOBEL BIOCARE AB - Branemark System Mk III Shorty RP 4,1 NOBEL BIOCARE AB - Branemark System Mk III TiUnite WP5 6 Straumann USA - Bone level NC 3.3 Straumann USA - Bone level RC 4.1 —4.8 Straumann USA - Tissue level RN 4,8 Straumann USA - Tissue level WN 6,5 Zimmer Dental Inc. - Tapered Screw-Vent 3.5, 4.5, 5.7 Zimmer Dental Inc. - Spline 3.25, 3.75-4, 5 ASTRA TECH AB - OsseoSpeed™ TX 3.5-4, 4.5-5 DENTSPLY INTL., INC. - ANKYLOS C/ 3,5 DENTSPLY INTERNATIONAL, INC. - FRIALIT plus Stepped Screw 3.4, 3.8, 4.5, 5.5, 6.5 BIOMET 3i - Certain 3.25, 4.1, 5, 6 IMPLANT DIRECT LLC - Legacy 3, 3.75, 4.7 IMPLANT DIRECT LLC - Tri-Lobe 3.5,4.3,5-6 IMPLANT DIRECT LLC - Tri-Lobe 3.5,4.3,5-6 IMPLANT DIRECT SYBRON MANUFACTURING LLC - Swish Plus3.7, 4.1 — 4.8 MIS - IMPLANT TECHNOLOGIES LTD. - SEVEN 3.3, 3.75,4.2, 5, 6 MIS - IMPLANT TECHNOLOGIES LTD. - C1 3.3, 3.75,3.9,4.2,4.3, 5 MEGAGEN CO., LTD. - ANYRIDGE 3.5, 4,4.5, 5, 5.5 NEODENT USA, INC. - CM Titamax 3.5, 3.75, 4,4.3, 5 NEODENT USA, INC. - CM Drive 3.5, 3.75, 4,4.3, 5 NEOSS, LTD. - ProActive 3.5, 4, 4.5, 5, 5.5, 6 BIOHORIZONS IMPLANT SYSTEMS, INC. - Laser-lok® 3.0 BIOHORIZONS IMPLANT SYSTEMS, INC. - Tapered internal 3.5, 4.5, 5.7 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM SD 3.5 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM RD 4.1 KEYSTONE DENTAL, INC. / LIFECORE BIOMEDICAL, INC - PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM WD 5

Source page: https://510kreport.com/device/K160382
Methodology: https://510kreport.com/methodology