# K034035: 3I Patient-Specific Overdenture Bar

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Mar 24, 2004 after 86 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 K944964 (1995). 20 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974150: Procera Preparable Abutment System, Nobel Biocare Uas, Inc. (1998) Summary page 1.
- (no number) Hader overdenture bars: named in the summary without a submission number
- (no number) Dolder overdenture bars: named in the summary without a submission number
- (no number) Primary overdenture bars: named in the summary without a submission number

## Most influential descendants
- K080864: Cam Structsure Precision Milled Bars (2008), 14 descendants of its own
- K180998: BioHorizons CAD/CAM Bars (2018), 9 descendants of its own
- K203252: Multi-unit Abutments for CONELOG (2021), 8 descendants of its own
- K213106: BTI Interna Dental Implant System UnicCa - Prosthetic Components (2022), 3 descendants of its own
- K240187: Tapered Pro Conical Implant System (2024), 2 descendants of its own

## Indications for use
The 3i Patient-Specific Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in an edentulous or partially edentulous patient. It is intended for use to support multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be screwed retained.

Source page: https://510kreport.com/device/K034035
Methodology: https://510kreport.com/methodology