# K072595: Omni-Tight

- Pathway: 510(k) (Special)
- Applicant: Basic Dental Implant Systems, Inc.
- Decided: May 9, 2008 after 238 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: 9 generations back to K925765 (1993). 65 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013682: Modification to Basic Dental Implant System, Basic Dental Implant Systems, Inc. (2001) Summary page 1.
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 4.
- K051189: Prevail Dental Implants, Implant Innovations, Inc. (2005) Summary page 4.
- K972417: The 6.0 X 8.0MM Dental Implant System, Bicon, Inc. (1997) Summary page 4.

## Most influential descendants
- K082749: Omni-Tight (2008), 0 descendants of its own

## Indications for use
The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).

Source page: https://510kreport.com/device/K072595
Methodology: https://510kreport.com/methodology