Bioline Dental Implant System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250872 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 Bioline Dental Implant System is a dental implant device designed for the replacement of missing teeth. It is classified under the product code DZE and is intended for osseointegrated fixation in the alveolar bone, providing a foundation for prosthetic restoration in oral and maxillofacial applications.
This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under the Traditional pathway. It is manufactured by Bioline Dental Implant Systems Ltd. and is distributed with detailed surgical instructions for use by dental professionals. The device is regulated under the Dental advisory committee and is approved for commercial distribution in the United States.
Frequently asked questions
What types of dental procedures is the Bioline Dental Implant System intended for, and how does it function in the mouth?
The Bioline Dental Implant System is designed specifically for replacing missing teeth by providing osseointegrated fixation in the alveolar bone. This means it integrates with the jawbone to create a stable foundation for prosthetic restorations, such as crowns or bridges, in oral and maxillofacial applications. It is not intended for general dental use but rather for targeted tooth replacement where a permanent anchor is needed.
Is the Bioline Dental Implant System meant for reuse, or is it single-use only? How does this affect its handling?
The Bioline Dental Implant System is explicitly intended for single-use only. This design ensures sterility and reduces the risk of cross-contamination between patients. Clinicians must follow the provided surgical instructions for use, which likely include proper handling, storage, and disposal protocols to maintain safety and compliance with sterile procedures.
How is the Bioline Dental Implant System regulated in the United States, and what does the FDA’s clearance status mean for its use?
The Bioline Dental Implant System has received FDA clearance under the Traditional 510(k) pathway, classified under product code DZE and reviewed by the Dental (DE) Advisory Committee. This clearance indicates that the FDA has determined the device is *substantially equivalent* to a legally marketed predicate device, meaning it meets the same performance standards and safety requirements. Clinicians can rely on this clearance to confirm the device adheres to U.S. regulatory standards for dental implants.
What should clinicians consider when storing the Bioline Dental Implant System to ensure its integrity before use?
Since the Bioline Dental Implant System is supplied sterile, clinicians must store it in a way that preserves sterility until use. The packaging likely includes protective barriers to prevent contamination, so it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s storage instructions included with the device to avoid compromising its sterility or performance.
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: Implants - BioLine Dental Implants Official 2024, About us - BioLine Dental Implants Official 2024, BioLine Dental Implants Official - BioLine Dental Implants Official, About us - BioLine Dental Implants Official
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250872 | Class II | Active |
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Manufacturer
- Manufacturer
- Bioline Dental Implant Systems Ltd
- FDA Applicant
- Bioline Dental Implant Systems, Ltd.
Sources (1)
- FDA 510(k) K250872 24 fields · synced Oct 6, 2026