# K033392: Immediate Stabilizing Implant (Isi)

- Pathway: 510(k) (Traditional)
- Applicant: O Co., Inc.
- Decided: Dec 10, 2003 after 48 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
Longest line of descent: 2 generations back to K820013 (1982). 10 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983120: Bicortical Screw, Oraltronics Marketing-Und Vertriebs GmbH (1999) Summary page 1.
- K982925: Laminoss Dental Implant, Impladent, Ltd. (1999) Summary page 1.
- K992512: Altiva Corporation NTR 3.3 MM Self-Tapping Screw Implants, Altiva Corporation Corporation NTR-3.3 MM Self-Tapping HA Coa, Imcor (1999) Summary page 1.
- K011502: Crystal and Crystal-Care Implants System, Crystal-Seal Dental Implants (2001) Summary page 1.

## Most influential descendants
- K090174: Tsi; Eri (2009), 4 descendants of its own
- K110337: Universal Maxillary Molar (2012), 1 descendant of its own
- K171197: Zuga Dental Implant System (2018), 0 descendants of its own
- K142846: BBX1, BBX2, BBX1MO, BBX1MC (2016), 0 descendants of its own
- K122198: 6.00MM X 6.00MM Macro External Implant System (2013), 0 descendants of its own

## Indications for use
The Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted between the mental foramina.

Source page: https://510kreport.com/device/K033392
Methodology: https://510kreport.com/methodology