# K063403: Conical Angled Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Mar 20, 2007 after 131 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933462 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933462: Conical Abutment, Implant Innovations, Inc. (1994) Summary page 1.

## Most influential descendants
- K101068: Accufit Dental Implant Abutments & Screws (2010), 0 descendants of its own

## Recalls of this device
- Nov 25, 2015 · Class II · Z-2514-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2513-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2505-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2504-2016: Pouches may not have been sealed during packing.
- Sep 28, 2011 · Not classified · Z-0158-2012: On 09/28/2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Conical Angled Abutment, Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478.

## Indications for use
3i's Conical Angled Abutments are indicated for use in single and multiple unit cases and as custom copings where tissue depth, as measured from the crest of the tissue to the shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations.

Source page: https://510kreport.com/device/K063403
Methodology: https://510kreport.com/methodology