# K934126: One and Two Piece Temporary Healing,(Emergence Profile) Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Apr 25, 1994 after 243 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
620 later devices descend from it; 13 cite it directly.
0 of 621 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
- K980083: 3I Orthodontic Abutment, Orthobutment (1998), 477 descendants of its own
- 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

## Recalls of this device
- Nov 25, 2015 · Class II · Z-2441-2016: Pouches may not have been sealed during packing.
- Sep 21, 2015 · Class II · Z-0592-2016: Inadequate biocompatibility testing.
- Sep 21, 2015 · Class II · Z-0591-2016: Inadequate biocompatibility testing.
- Feb 23, 2010 · Not classified · Z-2799-2011: Biomet 3i of Palm Beach Gardens, FL is recalling their Certain EP Healing Abutment (IWTH56). The Healing Abutment dimensions did not match outside label and laser etching on part. The product was actu
- Apr 25, 2007 · Not classified · Z-0811-2007: The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
- Oct 16, 2006 · Not classified · Z-0922-2007: Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
- Oct 4, 2004 · Not classified · Z-0029-05: The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.

Source page: https://510kreport.com/device/K934126
Methodology: https://510kreport.com/methodology