# K042354: Modification to: Cresco TI Implant Concept

- Pathway: 510(k) (Special)
- Applicant: Cresco TI Systems AB
- Decided: Sep 21, 2004 after 22 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Cresco Ti Implant: named in the summary without a submission number

## Indications for use
The Cresco Ti® Implant Concept is intended a) for implantation into the fully edentulous ridge for the support of a dental prosthesis; b) for implantation into the partially edentulous ridge for support of a dental prosthesis; c) for single tooth implantation use.

Source page: https://510kreport.com/device/K042354
Methodology: https://510kreport.com/methodology