Osseotite IOL Implants and Osseotite Certain IOL Implants
by Implant Innovations, Inc. 510(k)
Active
510(k) K031632
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK031632 | Date16 Sep 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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 Osseotite IOL Implants and Osseotite Certain IOL Implants are classified as Implant, Endosseous, Root-form (product code DZE), designed for surgical placement in the upper or lower jaw. These devices provide a foundation for prosthetic attachment, integrating with bone to support dental restorations. Constructed for dental applications, they are intended to replace missing teeth by anchoring prosthetic components within the alveolar ridge. Their design facilitates osseointegration, ensuring stability and long-term functionality.
These implants are supplied as single-use devices and are regulated under FDA 510(k) clearance (K031632) with a Traditional clearance type, classified as Class II under Special Controls. They are intended for use in dental surgical settings and must be handled under sterile conditions. The devices are available in various sizes and configurations to accommodate different anatomical requirements. Storage and handling must comply with FDA regulations and manufacturer guidelines to maintain sterility and performance.
Other devices from Implant Innovations, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are Osseotite IOL Implants used for?
Osseotite IOL Implants are designed to replace missing teeth by providing a stable foundation for dental prosthetics. They integrate with the bone in the alveolar ridge through osseointegration, ensuring long-term stability for crowns, bridges, or other restorations. This process mimics natural tooth root attachment, allowing the implant to function like a biological tooth.
Are OsseOTite IOL Implants single-use or reusable?
These implants are intended for single-use only. The design and regulatory classification (FDA 510(k) clearance) emphasize sterile handling and one-time surgical placement to maintain safety and performance. Reuse is not permitted to prevent contamination or compromise of sterility.
What sizes and configurations are available for OsseOTite IOL Implants?
OsseOTite IOL Implants come in various sizes and configurations tailored to accommodate different anatomical requirements in the upper or lower jaw. The exact dimensions and models should be referenced in the manufacturer’s product catalog or surgical guide, as they are engineered to match specific patient needs for optimal osseointegration and prosthetic fit.
How should OsseOTite IOL Implants be stored to maintain sterility?
Storage must comply with FDA regulations and the manufacturer’s guidelines to preserve sterility. The implants should be kept in their original, sealed packaging until ready for use. Exposure to moisture, temperature extremes, or contamination risks must be avoided, as these can compromise the device’s integrity and performance during surgery.
What regulatory clearance applies to OsseOTite IOL Implants?
OsseOTite IOL Implants hold FDA 510(k) clearance under the product code DZE (Implant, Endosseous, Root-form) with a Traditional clearance type. This classification confirms they meet FDA standards for safety and effectiveness as dental implants, ensuring compliance with special controls for endosseous devices.