# K980549: Osseotite Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations, Inc.
- Decided: Apr 28, 1998 after 90 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; 9 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 its predicate without a number.
- (no number) 3i standard and self-tapping implants: named in the summary without a submission 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 to restore a patient’s chewing function. This submission provides information and animal/clinical data to support a clinical performance claim of “Enhanced Performance in Poor Quality Bone”.

Source page: https://510kreport.com/device/K980549
Methodology: https://510kreport.com/methodology