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The Prodigy System Dental Implants

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042429

by BioHorizons Implant Systems, Inc.

Identifiers

510(k) Number
K042429 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 Prodigy System Dental Implants are endosseous, root-form dental implants designed for osseointegration within the jawbone. These implants serve as artificial tooth roots to support dental prosthetics, including crowns, bridges, or dentures, restoring function and aesthetics in patients with missing teeth.

The system is intended for use in dental offices and oral surgery settings, supplied sterile for single-use. Implants are classified under product code DZE and were granted FDA 510(k) clearance under Special Review (SESE) in 2004. Sizes and configurations are specified in the manufacturer’s technical documentation, adhering to dental implant standards for biocompatibility and structural integrity.

Frequently asked questions

Are the Prodigy System Dental Implants designed for reuse, or are they intended for single-use only?

The Prodigy System Dental Implants are supplied sterile for single-use only. This ensures patient safety and maintains sterility standards required for dental implant procedures, as outlined in the manufacturer’s specifications.

What types of dental restorations can the Prodigy System support, and how do they function?

The Prodigy System is designed to serve as artificial tooth roots for osseointegration within the jawbone, supporting dental prosthetics such as crowns, bridges, or dentures. By integrating with the bone, it provides a stable foundation to restore both function and aesthetics in patients with missing teeth.

How are the Prodigy System implants categorized under regulatory classifications, and what does that mean for their use?

The Prodigy System falls under FDA product code DZE, which classifies it as a dental implant. It was granted FDA 510(k) clearance under Special Review (SESE) in 2004, meaning it was deemed substantially equivalent to a legally marketed predicate device. This classification ensures it meets regulatory standards for safety and effectiveness in dental office and oral surgery settings.

What should I consider when storing the Prodigy System implants before use?

Since the Prodigy System is supplied sterile for single-use, proper storage is critical to preserve sterility and integrity. The manufacturer’s technical documentation provides specific guidelines, but generally, implants should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, following standard sterile packaging protocols for dental implants.

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: Implant Dentistry Products and Solutions - BioHorizons, THE PRODIGY SYSTEM DENTAL IMPLANTS (K042429) — FDA 510 (k) | Innolitics, THE PRODIGY SYSTEM DENTAL IMPLANTS 510(k) K042429 - FDA.report, PDF K042429 - the Prodigy System Dental Implants, Products for Dental Implantology and Oral Surgery - BioHorizons

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) K042429 24 fields · synced Sep 19, 2026