# K891613: Overdenture Attachment

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations International, Inc.
- Decided: Oct 10, 1989 after 204 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
551 later devices descend from it; 3 cite it directly.
0 of 552 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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
- K030614: 3I Dental Implants (2003), 319 descendants of its own
- K041402: Modification to Osseotite NT Certain Implants (2004), 318 descendants of its own

## Recalls of this device
- Nov 25, 2015 · Class II · Z-2459-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2461-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2425-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2424-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2460-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2426-2016: Pouches may not have been sealed during packing.

Source page: https://510kreport.com/device/K891613
Methodology: https://510kreport.com/methodology