# K082749: Omni-Tight

- Pathway: 510(k) (Special)
- Applicant: Basic Dental Implant Systems, Inc.
- Decided: Dec 4, 2008 after 76 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: 10 generations back to K925765 (1993). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072595: Omni-Tight, Basic Dental Implant Systems, Inc. (2008) Summary page 1.
- K061629: Certain Prevail Dental Implant, Implant Innovations, Inc. (2007) Summary page 2.
- K071235: Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13, Zimmer Dental, Inc. (2007) Summary page 2.
- K070022: Mistral - One Stage Screw-Type Dental Implant, Model MF9, Mis Implants Technologies, Ltd. (2007) Summary page 2.
- K041938: Maximus OS (Overdenture System), BioHorizons Implant Systems, Inc. (2004) Summary page 2.

## 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 supra-structures (false teeth).

Source page: https://510kreport.com/device/K082749
Methodology: https://510kreport.com/methodology