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allied biocompat abutment for nobel replace interface
Allied Dental Solutions
Summary: The Allied Biocompat Abutment is a dental device used in implantology to connect dental implants to prosthetic teeth. It is primarily used by dental professionals in restorative dentistry.
FDA Clearance Information
Pathway
510K
Number
K152845 ↗
Decision Date
March 14, 2016
Product Code
NHA
Device Class
Class 2
Evidence
0 studies
The Allied Biocompat Abutment was cleared through the FDA 510(k) pathway on March 14, 2016. Manufactured by Allied Dental Solutions, it is classified as a Class 2 device under product code NHA.
What It Is
The Allied Biocompat Abutment is a dental component designed to connect a dental implant to a prosthetic tooth or crown. It serves as an intermediary, ensuring the stability and alignment of the prosthetic tooth. Made from biocompatible materials, it minimizes the risk of adverse reactions and promotes osseointegration, which is the direct structural and functional connection between living bone and the surface of a load-bearing artificial implant.
Clinical Applications
This abutment is commonly used in dental implant procedures, particularly in restorative dentistry. It is suitable for patients requiring tooth replacement due to tooth loss from decay, trauma, or periodontal disease. Dental specialists, such as prosthodontists and oral surgeons, typically utilize this device in both outpatient dental clinics and hospital settings.
Indications for Use
The FDA-cleared indications suggest that this abutment is intended for patients who need a secure connection between a dental implant and a prosthetic tooth. It is particularly beneficial for those undergoing tooth replacement procedures.
Practical Considerations
The Allied Biocompat Abutment is available in various sizes to accommodate different implant systems and patient anatomies. It is compatible with the Nobel Replace interface, ensuring versatility in clinical practice. Proper technique in placing the abutment is crucial for optimal outcomes, including ensuring tight connections to prevent micro-movements.
Frequently Asked Questions
What is the Allied Biocompat Abutment used for?
It is used to connect dental implants to prosthetic teeth, providing stability and alignment in dental restorations.
What specialties typically use this device?
Prosthodontists and oral surgeons in restorative dentistry commonly use this device.
What are the FDA-cleared indications?
It is indicated for connecting dental implants to prosthetic teeth in patients undergoing tooth replacement procedures.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.