# K962465: TIL313 Abutment and Retaining Screw Systems

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Sep 20, 1996 after 87 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
No predicates in its family tree.
673 later devices descend from it; 2 cite it directly.
0 of 674 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 no predicate by number.

## Most influential descendants
- K032263: 3I Patient-Specific Dental Abutment and Overdenture Bar (2004), 476 descendants of its own
- K022113: 3I Dental Implant Accessories (2002), 463 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
- K030614: 3I Dental Implants (2003), 319 descendants of its own

## Indications for use
Abutments are designed for use in dental implant surgery. The 3i system includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants and abutments. The implants are surgically inserted into upper and/or lower jawbones and upon healing an abutment may be placed on the implant, extending the implant's coronal aspect through the soft tissues and into the oral cavity. A prostheses is then attached to the Abutment. A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium or titanium alloy implant when surgically implanted under controlled conditions, per well known clinical studies.

Source page: https://510kreport.com/device/K962465
Methodology: https://510kreport.com/methodology