# K043226: Endure Implant, Models 3508, 4308, 3520, 4320

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Jan 13, 2005 after 52 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
To replace missing tooth roots for single tooth, partial tooth, and fully edentulous patients. ENDURE endosseous implants are designed to become an Osseointegrated prosthesis allowing the attachment of a partial or a complete prosthodontic appliance in the mandible or maxilla.

Source page: https://510kreport.com/device/K043226
Methodology: https://510kreport.com/methodology