# K112730: Abutment for Competitive Implant Straumann Bone Level Connection

- Pathway: 510(k) (Special)
- Applicant: Biomet 3i
- Decided: Jan 13, 2012 after 115 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K894595 (1990). 20 ancestors in all.
9 later devices descend from it; 2 cite 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)
- K110565: Abutments for Competitive Implant Systems-Nobel Replace, Biomet 3i, Inc. (2011)

## Most influential descendants
- 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
- K232170: Ti Link Abutment (2024), 0 descendants of its own

## Recalls of this device
- Nov 25, 2015 · Class II · Z-2423-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2422-2016: Pouches may not have been sealed during packing.

## Indications for use
BIOMET 3i Dental Abutments are intended for use as accessories to endlosseous 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 or cement retained to the abutment. For compatibility of.BellatekTM Patient Specific Abutments, please refer to the Table below.

Source page: https://510kreport.com/device/K112730
Methodology: https://510kreport.com/methodology