# K013682: Modification to Basic Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: Basic Dental Implant Systems, Inc.
- Decided: Nov 28, 2001 after 21 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: 1 generation back to K960868 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960868: B.a.S.I.C. Dental Implant System, Danlin Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K072595: Omni-Tight (2008), 1 descendant of its own
- 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/K013682
Methodology: https://510kreport.com/methodology