Spline X Endosseous Dental Implant System

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

510(k) Number

K962576 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• O-Ring Prosthetic Attachment Device

  Class II

  FDA 510(k) K900545 Active Cleared 22 Jun 1990

• Calcitek Torque Wrench System

  Class II

  FDA 510(k) K931440 Active Cleared 26 Jan 1994

• Integral III Biointegrated Dental Implant System

  Class II

  FDA 510(k) K925490 Active Cleared 1 Aug 1994

• Integral Plus Biointegrated Dental Implant System

  Class II

  FDA 510(k) K900549 Active Cleared 28 Jun 1990

• Bur, Dental (76EJL)

  Class II

  FDA 510(k) K915597 Active Cleared 5 Feb 1992

• Calcitek Ha-Coated Endosseous Dental Implant Systems

  Class II

  FDA 510(k) K960021 Active Cleared 8 Feb 1996

See all devices from Calcitek, Inc. →

• What is the Spline X Endosseous Dental Implant System used for?

  The Spline X Endosseous Dental Implant System is designed for endosseous integration within the jawbone to serve as a stable foundation for dental prosthetics. This includes applications such as single-tooth replacement or bridgework, restoring oral function and stability for patients needing dental restoration. Its cylindrical titanium alloy construction with a porous titanium coating promotes osseointegration, ensuring long-term stability.

• How is the Spline X Endosseous Dental Implant System supplied, and what does sterile mean in this context?

  The Spline X Endosseous Dental Implant System is supplied sterile, meaning it undergoes processing to eliminate or reduce viable microorganisms to ensure safety for clinical use. Sterility is critical for preventing infection in surgical procedures, and this system adheres to medical device sterility standards to guarantee reliability in dental restoration procedures.

• Are individual Spline X implants single-use, or can they be reused?

  Individual Spline X Endosseous Dental Implant System implants are intended for single-use only. However, the surgical kits containing these implants are reusable, provided they are handled and stored according to sterile medical device protocols. Reusing individual implants could compromise sterility and patient safety.

• How do I identify the diameter of a Spline X implant, and why does this matter?

  The Spline X Endosseous Dental Implant System implants are available in various diameters, which are color-coded on the packaging and surgical kits. This color-coding helps clinicians select the appropriate size for the patient’s specific anatomical requirements, ensuring proper fit, stability, and successful osseointegration during dental restoration procedures.

• What storage and handling guidelines should be followed for the Spline X Endosseous Dental Implant System?

  The Spline X Endosseous Dental Implant System must be stored and handled in compliance with sterile medical device protocols to maintain its integrity and sterility. This includes proper packaging, protection from contamination, and adherence to manufacturer-recommended storage conditions. Failure to follow these guidelines could compromise the implant’s performance and patient safety.