đź“‹ FDA Reference
frialit r -2 stepped screw with deep profile surface
Friatec Medical Inc., U
Summary: The Frialit R-2 Stepped Screw with Deep Profile Surface is a dental implant used primarily in oral surgery and implantology. It is utilized by dental specialists to provide stable anchorage for prosthetic teeth.
FDA Clearance Information
Pathway
510K
Number
K945847 ↗
Decision Date
March 15, 1996
Product Code
DZE
Device Class
Class 2
Evidence
0 studies
The Frialit R-2 Stepped Screw was cleared through the FDA 510(k) pathway on March 15, 1996. Manufactured by Friatec Medical Inc., it is classified as a Class II medical device.
What It Is
The Frialit R-2 Stepped Screw is a dental implant with a unique deep profile surface designed to enhance osseointegration. It is used in oral surgery to replace missing teeth by providing a stable foundation for dental prosthetics. The stepped screw design aids in distributing stress and improving stability in the jawbone.
Clinical Applications
This device is commonly used in dental implantology, particularly in cases requiring robust anchorage for prosthetic teeth. It is suitable for use in both general dental practices and specialized oral surgery settings. The Frialit R-2 is typically used in adult patients who have lost teeth due to trauma, decay, or periodontal disease.
Indications for Use
The Frialit R-2 Stepped Screw is indicated for use in patients requiring dental implants to replace missing teeth. It is suitable for individuals with adequate bone density to support the implant and is used to restore function and aesthetics in the oral cavity.
Practical Considerations
The Frialit R-2 comes in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard dental implantology tools and requires precise surgical technique to ensure optimal placement and integration.
Frequently Asked Questions
What is the Frialit R-2 Stepped Screw used for?
It is used as a dental implant to provide stable anchorage for prosthetic teeth in patients with missing teeth.
What specialties typically use this device?
This device is primarily used by oral surgeons and dental implantologists.
What are the FDA-cleared indications?
The device is indicated for use in patients needing dental implants to replace missing teeth, provided they have adequate bone density.
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.