đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For connecting a dental implant to a prosthetic tooth or crown.
- For use with compatible Nobel Replace implant interfaces in dental implant restorations.
Clinical Applications
- Supporting a single-tooth crown on a compatible dental implant.
- Connecting a compatible dental implant to a fixed prosthetic restoration.
- Providing an intermediate connection between the implant fixture and the prosthetic tooth.
- Use during restorative treatment for patients receiving implant-supported tooth replacement.
Practical Considerations
- The abutment should be used only with the compatible Nobel Replace interface and matching components.
- Available dimensions and configurations must be selected to match the implant system, restoration, soft tissue, and patient anatomy.
- Correct seating and tightening are important to reduce micromovement, loosening, and mechanical complications.
- The FDA record and supplied labeling should be reviewed for material composition, sterilization requirements, contraindications, and handling instructions.
- MRI safety should not be assumed from the device name alone; the dentist or radiology team should verify the implant and abutment materials and the manufacturer's current MRI labeling.
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.