Endure Implant, Model 3508, 3511, 3514, 4308, 4311, 4314
by Imtec Corp.
510(k) K030243
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030243 | Date23 Apr 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Endure Implant, Models 3508, 3511, 3514, 4308, 4311, and 4314 are endosseous dental implants designed to replace missing tooth roots. These implants integrate with the jawbone through osseointegration, providing a stable foundation for partial or complete prosthodontic appliances. They are intended for single-tooth, partial-tooth, and fully edentulous patients requiring dental restoration. The device falls under the product code DZE, classified as a dental implant under FDA regulations.
These implants are supplied as reusable medical devices and are intended for use in clinical dental settings by trained professionals. They undergo FDA clearance through a 510(k) premarket notification process, with the current authorization dated April 23, 2003. The models vary in dimensions and threading to accommodate different patient anatomies and clinical needs. Sterility and handling instructions are provided by the manufacturer to ensure proper surgical application and integration with prosthetic components.
Other devices from Imtec Corp.
Questions
AI-generated answers, 1 Oct 2026
What are the Endure Implant Models 3508, 3511, 3514, 4308, 4311, and 4314 used for?
These implants replace missing tooth roots by integrating with the jawbone through osseointegration, providing a stable foundation for partial or full prosthodontic appliances. They are suitable for single-tooth, partial-tooth, and fully edentulous patients requiring dental restoration. The varying models accommodate different patient anatomies and clinical needs.
Are the Endure Implant Models reusable or single-use?
The Endure Implant Models 3508, 3511, 3514, 4308, 4311, and 4314 are designed as reusable medical devices. They are intended for clinical dental settings and must be handled according to manufacturer guidelines to ensure proper surgical application and integration with prosthetic components.
How do the different models differ from each other?
The Endure Implant models vary in dimensions and threading to better suit different patient anatomies and clinical requirements. For example, Model 3508 may have different diameter or length specifications compared to Model 4308, allowing for customized placement based on individual patient needs. The manufacturer provides detailed specifications for each model.
What sterility and handling instructions apply to these implants?
The Endure Implant Models follow manufacturer-provided sterility and handling protocols to ensure safe surgical application. These instructions are critical for maintaining implant integrity and preventing contamination before and during use. Clinicians must adhere to these guidelines to ensure proper integration with prosthetic components.
What regulatory pathway does the Endure Implant follow?
The Endure Implant Models 3508, 3511, 3514, 4308, 4311, and 4314 underwent FDA clearance through a 510(k) premarket notification process, classified under product code DZE. The clearance was granted on April 23, 2003, and the device is considered substantially equivalent to a legally marketed predicate.