# K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Jan 28, 2004 after 189 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K944964 (1995). 34 ancestors in all.
476 later devices descend from it; 10 cite it directly.
0 of 511 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012911: 3I Locater Abutment System, Implant Innovations, Inc. (2001) Summary page 1.
- K991947: 3I Ceramic Abutment System, Implant Innovations, Inc. (1999) Summary page 1.
- K980083: 3I Orthodontic Abutment, Orthobutment, Implant Innovations, Inc. (1998) Summary page 2.
- K965077: Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained Restorations, Implant Innovations, Inc. (1997) Summary page 2.
- K962465: TIL313 Abutment and Retaining Screw Systems, Implant Innovations, Inc. (1996) Summary page 2.
- K932123: Implant Innovation Pre-Angled Abutment System, Implant Innovations International, Inc. (1994) Summary page 2.
- K933462: Conical Abutment, Implant Innovations, Inc. (1994) Summary page 2.
- K933969: Tapered Abutment and Related Components, Implant Innovations, Inc. (1994) Summary page 2.
- K934126: One and Two Piece Temporary Healing,(Emergence Profile) Abutments, Implant Innovations, Inc. (1994) Summary page 2.
- K891613: Overdenture Attachment, Implant Innovations International, Inc. (1989) Summary page 2.
- K871863: Adbutment Cylinder and Screw, Implant Innovations International, Inc. (1987) Summary page 2.
- K974150: Procera Preparable Abutment System, Nobel Biocare Uas, Inc. (1998) Summary page 2.
- K981858: Atlantis Abutment and Atlantis Abutment Screw, Atlantis Components, Inc. (1999) Summary page 2.

## Most influential descendants
- K042658: Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (2004), 441 descendants of its own
- K043042: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 (2004), 327 descendants of its own
- K090069: Procera Implant Bridge Overdenture (2009), 313 descendants of its own
- K091756: Nobelprocera TI Abutment (2009), 278 descendants of its own
- K052070: Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini + Abutment in Zirconia (2005), 261 descendants of its own

## Recalls of this device
- Aug 26, 2013 · Class II · Z-1215-2014: Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.

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

Source page: https://510kreport.com/device/K032263
Methodology: https://510kreport.com/methodology