CP4 Osseotite Certain Dental Implants
FDA 510(k)Class II (US FDA 510(k))
by Biomet 3i
Identifiers
- 510(k) Number
- K130949 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CP4 Osseotite Certain Dental Implants are titanium dental implants designed for osseointegration in the jawbone. Their acid-etched surface promotes direct bone-to-implant contact, facilitating stable integration and long-term support for prosthetic teeth. These implants are categorized under dental implant systems and are intended for use in reconstructive oral and maxillofacial procedures.
These implants are supplied sterile and intended for single-use. They are regulated under FDA 510(k) clearance (K130949) as substantially equivalent to a predicate device, classified under product code DZE. The CP4 designation indicates a specific implant size or design variant, and they are distributed in sterile packaging for surgical use in controlled clinical settings. No MRI safety information is provided in the specifications.
Frequently asked questions
What is the CP4 Osseotite Certain Dental Implant designed for?
The CP4 Osseotite Certain Dental Implant is specifically designed for osseointegration in the jawbone, providing stable support for prosthetic teeth. Its acid-etched titanium surface promotes direct bone-to-implant contact, which is essential for long-term integration and success in reconstructive oral and maxillofacial procedures.
How is the CP4 Osseotite Certain Dental Implant supplied and intended for use?
The CP4 Osseotite Certain Dental Implant is supplied sterile in packaging tailored for surgical use. It is intended for single-use only, ensuring patient safety and compliance with clinical best practices in controlled surgical settings.
What distinguishes the CP4 designation in this implant system?
The CP4 designation refers to a specific size or design variant within the Osseotite Certain Dental Implant system. This designation helps clinicians select the appropriate implant dimensions for their patient’s unique anatomical requirements during reconstructive procedures.
Are these implants reusable or intended for single-use?
The CP4 Osseotite Certain Dental Implants are explicitly intended for single-use. This design ensures sterility and reduces the risk of cross-contamination, aligning with medical best practices for implantable devices.
What regulatory pathway does this implant follow?
The CP4 Osseotite Certain Dental Implant follows the FDA 510(k) clearance pathway, classified under product code DZE. It was determined to be substantially equivalent to a predicate device, with clearance granted on July 30, 2013, under the traditional review process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Biomet 3i Certain® Dental Implants - Preat Corporation, PDF Certain Implant System - BIOMET 3i, Osseotite Implants | ZimVie Americas, PDF Product Catalog - BIOMET 3i
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130949 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet 3i
Sources (1)
- FDA 510(k) K130949 24 fields · synced Oct 1, 2026