# K092341: Low Profile Abutments - Internal and External Connection

- Pathway: 510(k) (Traditional)
- Applicant: Biomet 3i, Inc.
- Decided: Nov 30, 2009 after 118 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
114 later devices descend from it; 4 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Conical Abutments (Straight and Angled): named in the summary without a submission number
- (no number) Immediate Occlusal Loading (IOL) Abutments: named in the summary without a submission number
- (no number) Asyst Abutment Delivery Device: named in the summary without a submission number

## Most influential descendants
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own
- K183518: Preat Abutments (2019), 22 descendants of its own
- K212628: DESS Dental Smart Solutions (2022), 20 descendants of its own

## Recalls of this device
- Sep 14, 2016 · Class II · Z-0829-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0832-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0834-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0835-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0838-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0845-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0856-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0858-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0860-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0830-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0833-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0841-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0842-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0844-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0848-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0851-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0852-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0854-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0859-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0861-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0862-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0836-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0837-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0840-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0843-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0846-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0847-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0853-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0857-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0863-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0828-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0831-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0839-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0849-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0850-2017: A limited number of product pouches may not have been sealed during packaging.
- Sep 14, 2016 · Class II · Z-0855-2017: A limited number of product pouches may not have been sealed during packaging.
- Nov 25, 2015 · Class II · Z-2463-2016: Pouches may not have been sealed during packing.
- Jan 10, 2012 · Not classified · Z-1456-2012: Biomet 3i initiated a recall for a small percentage of the 33mm (ILPAC3217) abutment packages that may contain the 5mm (ILPAC5217) abutment.
- Mar 14, 2011 · Not classified · Z-2884-2011: Biomet 3i, Palm Beach Gardens, FL is recalling the Model LPCCC2 Low Profile Abutment, Non-Hexed Castable Cylinder, Lots 2010101036 and 2010101037 Exp. 10/2015. Package labeling may not correctly descr

## Indications for use
BIOMET 3i Low Profile 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 is screw retained to the abutment.

Source page: https://510kreport.com/device/K092341
Methodology: https://510kreport.com/methodology