Identifiers
- 510(k) Number
- K030463 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 Maestro System Modification is a screw-type dental implant system classified as a dental implant (DZE) under the FDA’s product code. It functions as an artificial root structure designed for single-tooth replacement or as abutments for fixed bridgework and denture retention in the mandible or maxilla. This modification maintains compatibility with the existing Maestro System while incorporating updated design elements to enhance performance or safety.
This device is intended for use in dental procedures and is supplied as a sterile, single-use implant system. The modification was submitted under a Special 510(k) pathway, indicating it is substantially equivalent to a previously cleared device. It is regulated under 21 CFR 807.92 and requires adherence to dental implant standards for placement in oral environments. No additional MRI safety or size-specific storage instructions are noted in the regulatory submission.
Frequently asked questions
What is the Maestro System Modification used for?
The Maestro System Modification is designed as an artificial root structure for single-tooth replacement or as abutments in fixed bridgework and denture retention. It is intended for placement in either the mandible or maxilla, providing a stable foundation for dental prosthetics. The updated design enhances performance or safety while remaining compatible with the existing Maestro System.
Is the Maestro System Modification single-use or reusable?
The Maestro System Modification is supplied as a sterile, single-use implant system. This ensures patient safety by preventing cross-contamination and maintains compliance with dental implant standards for oral use.
How is the regulatory status of this modification determined?
This modification was submitted under a Special 510(k) pathway and is classified as substantially equivalent to a previously cleared device. The FDA determined it meets dental implant standards (DZE product code) under 21 CFR 807.92, ensuring it adheres to safety and effectiveness requirements for dental implants.
Are there any special storage instructions for this implant?
No specific MRI safety or size-specific storage instructions are noted in the regulatory submission for the Maestro System Modification. Standard sterile storage practices for dental implants should be followed to preserve sterility and integrity until use.
What distinguishes this modification from the original Maestro System?
The Maestro System Modification incorporates updated design elements while maintaining compatibility with the original Maestro System. These changes are intended to enhance performance or safety, though the exact modifications are not detailed in the regulatory submission. It retains the same screw-type implant classification for dental applications.
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: MODIFICATION TO THE MAESTRO SYSTEM by BIOHORIZONS IMPLANT SYSTEMS, INC ..., MODIFICATION TO THE MAESTRO SYSTEM - Innolitics, MODIFICATION TO THE MAESTRO SYSTEM - Innolitics, PDF MODIFICATION TO THE MAESTRO SYSTEM 510(k) K020133 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030463 | Class II | Active |
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Manufacturer
- Manufacturer
- BioHorizons Implant Systems, Inc.
Sources (1)
- FDA 510(k) K030463 24 fields · synced Oct 1, 2026