Core-Vent Endosseous Implant Abutments

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

510(k) Number

K900180 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Screw-Vent Implant

  Class II

  FDA 510(k) K950578 Active Cleared 11 Jul 1995

• Sub-Vent (Tm) Implant/Endosseous Blade Implant

  Class II

  FDA 510(k) K861425 Active Cleared 5 Nov 1986

• Bio-Vent Implant

  Class II

  FDA 510(k) K950575 Active Cleared 11 Jul 1995

• Pre-Angled Abutments

  Class II

  FDA 510(k) K912059 Active Cleared 11 Feb 1992

• Screw-Vent Endosseous Ha Coated Dental Implants

  Class II

  FDA 510(k) K902969 Active Cleared 17 Dec 1990

• Tsir Angled Abutments

  Class II

  FDA 510(k) K910585 Active Cleared 4 Oct 1991

See all devices from Core-Vent Corp. →

• What materials are the Core-Vent Endosseous Implant Abutments made from and why does that matter?

  The Core-Vent Endosseous Implant Abutments are manufactured from titanium or titanium alloy. This material choice is critical because titanium is widely recognized for its biocompatibility, meaning it is well-tolerated by the human body without causing adverse reactions. Additionally, titanium’s strength and durability ensure the abutments can withstand the functional demands of dental restorations like crowns or bridges while maintaining stability within the jawbone.

• Are these abutments intended for reuse or single-use, and how should they be handled before use?

  The Core-Vent Endosseous Implant Abutments are explicitly designed for single-use only. Since they are intended for surgical integration into the jawbone, they must be handled under sterile conditions to prevent infection. They should be stored in their original packaging until use, ensuring the sterile barrier remains intact until the procedure begins.

• What types of prosthetic restorations can these abutments support, and how do they function?

  These abutments are surgically integrated into the jawbone as part of an endosseous dental implant system, providing a stable foundation for prosthetic restorations such as crowns or bridges. Their function is to connect the implant fixture (embedded in the bone) to the final restoration, ensuring proper alignment, bite force distribution, and long-term stability for restored oral function and aesthetics.

• How are these abutments classified under FDA regulations, and what does that mean for their use?

  The Core-Vent Endosseous Implant Abutments are classified under the Dental (DE) advisory committee with product code DZE and hold FDA 510(k) clearance through the Traditional pathway. This classification means they are regulated as dental devices intended for endosseous implant systems, and their design was determined to be substantially equivalent to a legally marketed predicate device. Clinically, this ensures they meet established safety and performance standards for use in dental implant procedures.