Identifiers
- 510(k) Number
- K210039 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 CORE1 Implant System is a dental implant designed for osseointegration within the jawbone, providing a foundation for prosthetic teeth. It features a Surface-Loaded Acid-etched (S.L.A.) implant surface, validated for enhanced initial fixation and accelerated bone integration.
This system is supplied as a reusable surgical implant fixture, abutment systems, and prosthetic tools, including guided surgery components. It is intended for use in dental clinics under sterile conditions, with implant placement followed by a six-week osseointegration period before prosthesis insertion. The system is authorised under FDA 510(k) clearance (K210039) as a dental implant device.
Frequently asked questions
What is the primary purpose of the CORE1 Implant System’s S.L.A. surface technology, and how does it benefit patients during the healing process?
The Surface-Loaded Acid-etched (S.L.A.) surface on the CORE1 Implant System is engineered to improve osseointegration—the process where bone grows directly into the implant. This technology enhances initial fixation and accelerates bone integration, which helps patients achieve faster and more stable healing within the six-week osseointegration period before prosthetic teeth are attached.
Is the CORE1 Implant System intended for single-use or can it be reused in multiple procedures, and what components are included in the surgical kit?
The CORE1 Implant System is designed as a reusable surgical implant fixture, meaning the core implant itself can be used in multiple procedures after proper sterilization. The system also includes reusable abutment systems and prosthetic tools, along with guided surgery components to assist in precise placement. Sterility must be maintained under clinical conditions for each use.
How long does the osseointegration period typically take with the CORE1 Implant System, and what does this mean for patients’ treatment timeline?
The CORE1 Implant System requires a six-week osseointegration period after implant placement before prosthetic teeth can be inserted. This structured timeline allows the implant to fully integrate with the jawbone, ensuring stability and long-term success for the final restoration.
What types of dental clinics or settings are the CORE1 Implant System’s guided surgery components intended for, and how do they assist in the procedure?
The guided surgery components of the CORE1 Implant System are designed for use in dental clinics to enhance precision during implant placement. These tools help align the implant accurately within the jawbone, reducing surgical complexity and improving outcomes by minimizing deviations from the planned trajectory.
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: About Us | Cybermed CORE1 Implant, CORE1 IMPLANT - Cybermed, Korean Dental Implant Manufacturer | CORE1 Implant, PDF Core1 Implant System - شایگان ونوس ایرانیان
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210039 | Class II | Active |
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Manufacturer
- Manufacturer
- Cybermed Inc.
- FDA Applicant
- Cybermed, Inc.
Sources (1)
- FDA 510(k) K210039 24 fields · synced Sep 19, 2026