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BioHorizons Dental Implant System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K964330

by BioHorizons Implant Systems, Inc.

Identifiers

510(k) Number
K964330 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 BioHorizons Dental Implant System is a dental implant system intended for use as an artificial root structure in the mandible and maxilla. It is indicated for single tooth replacement or as abutments for fixed bridgework and denture retention.

The device is supplied by BioHorizons Implant Systems, Inc. and has received FDA 510(k) clearance under K964330 with product code DZE. It is classified under the Dental advisory committee and was determined to be substantially equivalent through a traditional review process.

Frequently asked questions

What is the BioHorizons Dental Implant System used for?

The BioHorizons Dental Implant System is intended for use as an artificial root structure in the mandible and maxilla, indicated for single tooth replacement or as abutments for fixed bridgework and denture retention.

How is the BioHorizons Dental Implant System supplied and cleared for use?

The device is supplied by BioHorizons Implant Systems, Inc. and has received FDA 510(k) clearance under K964330 with product code DZE, determined to be substantially equivalent through a traditional review process.

What regulatory pathway and classification apply to the BioHorizons Dental Implant System?

The BioHorizons Dental Implant System was cleared via the FDA 510(k) pathway under K964330, classified under the Dental advisory committee (product code DZE), and found substantially equivalent through a traditional review.

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: Products for Dental Implantology and Oral Surgery - BioHorizons, Implant Dentistry Products and Solutions - BioHorizons, Biohorizons Dental Implant System (Name Subject to Change), BioHorizons Dental Implants - Henry Schein

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
BioHorizons Implant Systems, Inc.

Sources (1)

  • FDA 510(k) K964330 24 fields · synced Sep 24, 2026