Interpore Cylindrical Hex Hydroxyapatite Coated Implant, 3.3 Mm Diam.

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K922872 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Ultracon Ultrafiltrator

  Class II

  FDA 510(k) K981253 Active Cleared 11 Dec 1998

• Imz Membrane Tack System

  Class II

  FDA 510(k) K960945 Active Cleared 24 May 1996

• Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000 Microns and 425 to 600 Microns

  Class II

  FDA 510(k) K950165 Active Cleared 28 Mar 1995

• Imz Intramobile Cylinder Implant

  Class II

  FDA 510(k) K855032 Active Cleared 3 Mar 1986

• Interpore Cylindrical Hex Implant, 3.3 Mm Diameter

  Class II

  FDA 510(k) K922732 Active Cleared 10 Feb 1994

• Interpore 200 Porous Hydroxyapatite

  Class II

  FDA 510(k) K860983 Active Cleared 23 May 1986

See all devices from Interpore Intl. →

• What is the primary purpose of the Interpore Cylindrical Hex Hydroxyapatite-Coated Implant, 3.3 mm Diameter?

  This implant is designed for endosseous dental restoration, providing durable, long-term support for prosthetic teeth. The cylindrical hex shape ensures mechanical stability during placement, while the hydroxyapatite coating promotes bone integration by encouraging natural bone growth around the implant surface. This dual approach minimizes micromotion, reducing the risk of implant failure and improving fixation in the jawbone.

• How is the Interpore Cylindrical Hex Hydroxyapatite-Coated Implant supplied, and what are its sterility and usage requirements?

  The implant is supplied as a sterile, single-use device, meaning it is intended for one-time surgical use only. It must be handled using aseptic techniques in a controlled surgical environment to maintain sterility. Single-use ensures patient safety by preventing cross-contamination and reduces the risk of infection associated with reuse.

• Is this implant reusable, or is it intended for single-use only?

  This implant is explicitly designed for single-use only. The sterile packaging and biocompatible materials are optimized for one surgical procedure to ensure patient safety and reliability. Reuse could compromise sterility, increase infection risks, and potentially alter the implant’s structural integrity or bone integration properties, which are critical for long-term success.

• What regulatory pathway does the Interpore Cylindrical Hex Hydroxyapatite-Coated Implant follow, and what does that mean for clinicians?

  The implant follows the FDA’s Traditional 510(k) clearance pathway, classified under product code DZE for dental implants. This means it was determined to be substantially equivalent to a legally marketed predicate device and meets FDA regulations for endosseous dental implants (872.3640). Clinicians can rely on its compliance with FDA standards, ensuring it meets established safety and performance criteria for dental restoration procedures.

• What materials is the Interpore Cylindrical Hex Hydroxyapatite-Coated Implant made from, and why does the hydroxyapatite coating matter?

  The implant is manufactured from biocompatible materials, with a hydroxyapatite coating applied to its surface. Hydroxyapatite is a bone-like mineral that accelerates osseointegration—the process where bone grows directly onto the implant surface. This coating enhances fixation by promoting natural bone growth, reducing the time required for healing and improving the implant’s long-term stability in the jawbone.