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510(k) Data Aggregation
K Number
K240435Device Name
Alpha Dent Implants Dental Implants System
Manufacturer
Alpha Dent Implants GmbH
Date Cleared
2024-12-20
(310 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Alpha Dent Implants GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
Superior Active and Active Bio Plus are a conical-shaped implant with a helical aggressive thread. It is used under one- or two-steps procedure in all bone types. The implant has a platform with an inner cone and a hexagon for positioning.
Superior Active and Active Bio Plus consist of the implant itself and a cover screw, which are packed in a titanium cuff filled with isotonic sodium chloride solution and a plastic flask.
The implant surface treatment method, known as Sandblasted, Large Grit, Acid-Etched (SLA), is a technique designed to roughen the surface of dental implants. The SLA process consists of two key steps: sandblasting with large grit particles to create a roughened texture, followed by acid etching to refine the surface.
The implant WET packaging process involves placing the implant in a protective titanium sleeve within a vial filled with NaCl 0.9% solution. The vial is sealed with a lid and placed inside a blister package. Both the plastic vial and the blister package serve as sterile barriers.
Additional abutments to the already submitted abutments in K210499: The abutments are anodized. Healing caps for implants with conical connection and Anatomical Titanium Shoulder Abutments and Healing caps for Multi-Unit System are also described.
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K Number
K210499Device Name
Alpha Dent Implants Dental Implants System
Manufacturer
Alpha Dent Implants GmbH
Date Cleared
2021-11-01
(252 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
Alpha Dent Implants GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
The Alpha Dent Implant Active Conus (IAK), Implant Classic Conus (ICK), Implant Active Bio (IAB) Dental Implants System consists of one or two stage Endosseous form dental implants, with same platform of implant/prosthetics abutments connection- internal hexagon for anti-rotation and internal cone, and It is intended to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
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