Opti-Max Internal-Hex Angled Implant Crown Post, 10 Degree & 20 Degree Inclinations

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K952592 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Opti-Max Externally Threaded Cylindrical Internal Bore Dental Implant, with Healing Screw

  Class II

  FDA 510(k) K955332 Active Cleared 6 May 1996

• Opti-Max Angled Crown Post for Externally-Hexed Implants, in 15 Degree and 25 Degree Inclinations. for Implants 3.3mm, 4

  Class II

  FDA 510(k) K972769 Active Cleared 13 Nov 1997

• Opti-Max Press-Fit External-Hex Dental

  Class II

  FDA 510(k) K944943 Active Cleared 13 Mar 1995

• Opti-Max Externally Threaded External-Hex Dental Implant, Titanium Plasma-Spray Coated, with Healing Screw

  Class II

  FDA 510(k) K952634 Active Cleared 18 Sep 1995

• Opti-Max Body Diameter W/5mm Top W/External Hex, Externally Threaded Dental Implant Coarse Threads

  Class II

  FDA 510(k) K960022 Active Cleared 24 May 1996

• What is the Opti-Max Internal-Hex Angled Implant Crown Post used for?

  The Opti-Max Internal-Hex Angled Implant Crown Post is a dental implant component designed for prosthetic restoration. It features an internal hex connection for secure attachment to implant abutments or crowns and is available in 10 degree and 20 degree inclinations to accommodate various clinical situations.

• Is the Opti-Max Internal-Hex Angled Implant Crown Post single-use or reusable?

  The Opti-Max Internal-Hex Angled Implant Crown Post is supplied as a single-use component. This means it should be used for one patient procedure only and should not be reused or resterilized for subsequent patient use to ensure safety and performance.

• What regulatory clearance has the Opti-Max Internal-Hex Angled Implant Crown Post received?

  The Opti-Max Internal-Hex Angled Implant Crown Post has received FDA 510(k) clearance with K952592 under product code DZE. It is classified as substantially equivalent and is intended for dental applications. The device is not indicated for MRI environments.

• How should the Opti-Max Internal-Hex Angled Implant Crown Post be stored?

  The Opti-Max Internal-Hex Angled Implant Crown Post should be stored according to manufacturer guidelines. While specific storage conditions aren't detailed in the provided information, dental implant components typically require storage in a clean, dry environment away from extreme temperatures and direct sunlight to maintain their integrity and performance.