# K980083: 3I Orthodontic Abutment, Orthobutment

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Aug 17, 1998 after 220 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934126 (1994). 1 ancestor in all.
477 later devices descend from it; 1 cites it directly.
0 of 479 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934126: One and Two Piece Temporary Healing,(Emergence Profile) Abutments, Implant Innovations, Inc. (1994) Summary page 7.

## Most influential descendants
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar (2004), 476 descendants of its own
- 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

## Indications for use
The 3i orthodontic abutment with 3i’s endosseous dental implant system is (are) indicated for use in orthodontic procedures, in which prior edentulism permits implantation of a root form implant into alveolar bone, as an anchor for fixation and abutment (support) of an orthodontic appliance.

Source page: https://510kreport.com/device/K980083
Methodology: https://510kreport.com/methodology