# K983347: Osseotite Dental Implants

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Jan 6, 1999 after 105 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.
601 later devices descend from it; 11 cite it directly.
0 of 602 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 no predicate by number.

## Most influential descendants
- K014235: Osseotite NT Dental Implants & Accessories (2002), 583 descendants of its own
- K013570: Osseotite Dental Implants (2001), 495 descendants of its own
- K022009: 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants (2002), 478 descendants of its own
- K022113: 3I Dental Implant Accessories (2002), 463 descendants of its own
- K062069: Atlantis Abutment for 3I Micromini Implant (2007), 361 descendants of its own

## Indications for use
An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment and to restore a patient’s chewing function. With use of OSSEOTITE® implants, the time between surgical implant placement and evaluation for prosthetic loading may be reduced from previously recommended four months (mandible) and six months (maxillary) to, two months for either mandibular or maxillary sites, when such evaluation confirms appropriate conditions for prosthetic attachment and masticatory loading.

Source page: https://510kreport.com/device/K983347
Methodology: https://510kreport.com/methodology