# K012911: 3I Locater Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Sep 28, 2001 after 29 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
675 later devices descend from it; 3 cite it directly.
0 of 676 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) Zest Locator® Anchor System: 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

## Recalls of this device
- Nov 25, 2015 · Class II · Z-2427-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2430-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2487-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2431-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2428-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2432-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2429-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2480-2016: Pouches may not have been sealed during packing.
- Nov 25, 2015 · Class II · Z-2433-2016: Pouches may not have been sealed during packing.
- Nov 23, 2009 · Not classified · Z-0810-2010: Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.
- Feb 7, 2008 · Not classified · Z-1363-2008: Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa

## Indications for use
Tissue supported overdentures on 2 to 4 implants Partially edentulous overdentures with one or more implants Overdentures with a minimum of 3.17mm of interarch distance Multiple implants with no greater than 40° of divergence between them

Source page: https://510kreport.com/device/K012911
Methodology: https://510kreport.com/methodology