# K110565: Abutments for Competitive Implant Systems-Nobel Replace

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, Inc.
- Decided: Sep 1, 2011 after 185 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: 5 generations back to K894595 (1990). 19 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020646: Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162, Nobel Biocare Uas, Inc. (2002) Summary page 1.
- K053654: Atlantis Abutment for Nobel Replace Interface, Atlantis Components, Inc. (2006) Summary page 1.
- K023113: Replace Tiunite Endosseous Implant, Nobel Biocare Uas, Inc. (2002) Summary page 1.

## Most influential descendants
- K112730: Abutment for Competitive Implant Straumann Bone Level Connection (2012), 9 descendants of its own
- K181037: DIO CAD/CAM Abutment (2018), 7 descendants of its own
- K222913: s-Clean Link Abutment (2023), 1 descendant of its own
- K210362: s-Clean Pre-Milled Abutment (2021), 1 descendant of its own
- K242703: LW Pre-milled Abutment (2024), 0 descendants of its own

## Indications for use
BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

Source page: https://510kreport.com/device/K110565
Methodology: https://510kreport.com/methodology