The 6.0 X 8.0mm Dental Implant System
FDA 510(k)Class II (US FDA 510(k))
by Bicon, Inc.
Identifiers
- 510(k) Number
- K972417 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)
This device is a dental implant system classified as a Dental Implant (Product Code DZE) designed for osseointegrated fixation in the jawbone. It features a 6.0 mm diameter and 8.0 mm length, engineered for use in specific edentulous sites requiring stable, long-term support for prosthetic restorations.
The 6.0 x 8.0 mm Dental Implant System is intended for surgical placement by dental professionals in the oral cavity. Supplied sterile for single-use, it adheres to FDA 510(k) clearance (K972417) under the Dental Device Exemptions (DE) pathway, with no MRI safety restrictions noted. Storage requires adherence to sterile packaging instructions until immediate preoperative use.
Frequently asked questions
What is the primary use of the 6.0 x 8.0 mm dental implant system, and who should place it?
The 6.0 x 8.0 mm dental implant system is designed for osseointegrated fixation in the jawbone, providing stable, long-term support for prosthetic restorations in edentulous (toothless) sites. It is intended for surgical placement *only* by qualified dental professionals in the oral cavity, as it requires precise placement for optimal integration with the bone.
Is this implant single-use or reusable, and how should it be stored before use?
This implant is supplied sterile for single-use only, meaning it should not be reused after one surgical procedure. Storage must follow the sterile packaging instructions provided, and it is intended for immediate preoperative use—do not open or remove from packaging until ready for surgery.
What dimensions define this implant, and how does that affect its application?
The implant has a 6.0 mm diameter and 8.0 mm length, making it suitable for specific edentulous sites where smaller or shorter implants are required. These dimensions are engineered to provide stable fixation in limited-space areas of the jawbone, ensuring compatibility with prosthetic restorations designed for this size.
Are there any special handling or safety considerations for this implant, such as MRI compatibility?
No MRI safety restrictions are noted for this implant, meaning it can be used in patients who require MRI scans without interference. However, it is critical to follow sterile packaging instructions strictly, as the implant is supplied sterile for single-use only, and improper handling could compromise its integrity or sterility.
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: Bicon SHORT® Implants - Bicon Dental Implants, The 6.0 X 8.0mm Dental Implant System 510 (k) FDA Premarket ..., THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM (K972417) — FDA 510(k ..., PDF CLINICALLY PROVEN - Bicon Dental Implants -, PDF K972417 - the 6.0 X 8.0mm Dental Implant System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972417 | Class II | Active |
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Manufacturer
- Manufacturer
- Bicon, Inc.
Sources (1)
- FDA 510(k) K972417 24 fields · synced Sep 19, 2026