KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM - Essential Solid (es)
FDA 510(k)Class II (US FDA 510(k))
by Soadco, S.l.
Identifiers
- 510(k) Number
- K080224 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
- Models / Variants
- Essential Cone (ec) FDA 510(k)Essential Solid (es) FDA 510(k)Eck 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 Klockner Essential Dental Implants System is a dental implant system designed for surgical insertion into bone to replace the root of teeth and act as support for dental prosthetics. It includes models Essential Cone (EC), Essential Solid (ES), and ECK, featuring an internal octagonal conical connection combined with an external octagonal connection for secure attachment of implant accessories.
The system is supplied as a set of implant models for use in dental surgical procedures. It received FDA 510(k) clearance under k-number K080224 with product code DZE and is classified under the Dental advisory committee. The device is manufactured by SOADCO, S.L. and was granted substantial equivalence on July 3, 2008.
Frequently asked questions
What is the Klockner Essential Dental Implants System used for?
The Klockner Essential Dental Implants System is designed for surgical insertion into bone to replace the root of missing teeth and provide stable support for dental prosthetics such as crowns, bridges, or dentures, enabling restoration of function and aesthetics in edentulous or partially edentulous patients.
What models are included in the Klockner Essential Dental Implants System?
The system includes three specific models: Essential Cone (EC), Essential Solid (ES), and ECK, each featuring an internal octagonal conical connection combined with an external octagonal connection to ensure secure and stable attachment of implant accessories like abutments and prosthetic components.
How is the Klockner Essential Dental Implants System supplied for clinical use?
The system is supplied as a set of implant models intended for use in dental surgical procedures, meaning clinicians receive the implants as sterile, ready-to-use components for direct implantation during oral surgery to support prosthetic rehabilitation.
What regulatory pathway was used for the Klockner Essential Dental Implants System?
The device received FDA 510(k) clearance under k-number K080224, demonstrating substantial equivalence to a legally marketed predicate device, and was granted this clearance on July 3, 2008, following review by the Dental advisory committee.
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: Klockner Essential Dental Implants System, Models Essential Cone (Ec ..., Essential® Cone | Klockner, Essential® Cone | Klockner
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080224 | Class II | Active |
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Manufacturer
- Manufacturer
- Soadco, S.l.
Sources (1)
- FDA 510(k) K080224 24 fields · synced Sep 21, 2026