# K965077: Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained Restorations

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Mar 17, 1997 after 90 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.
674 later devices descend from it; 4 cite it directly.
0 of 675 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 its predicate without a number.
- (no number) 3i Standard Abutment systems: named in the summary without a submission number
- (no number) 3i Tapered Abutment systems: named in the summary without a submission number
- (no number) 3i Conical Abutment systems: named in the summary without a submission number
- (no number) 3i Abutment Posts: named in the summary without a submission number
- (no number) Nobel Bio-Care “Cera-One” abutment systems: named in the summary without a submission 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
The -:STA abutment system is indicated for use on pruperly placed and healed dental implants, to extend the coronal aspect of the implant through soft gingival tissues into the oral cavity to provide the attachment mechaniem for cement retained, single tooth restorations to restore a patient's chewing function.

Source page: https://510kreport.com/device/K965077
Methodology: https://510kreport.com/methodology