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Salvin Tenting Screw System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161857

by Salvin Dental Specialties

Identifiers

510(k) Number
K161857 FDA 510(k)
FDA Product Code
DZL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.4880 FDA 510(k)
Regulation Number
872.4880 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Salvin Tenting Screw System is an intraosseous fixation device designed for dental applications. It consists of titanium alloy screws intended to stabilize bone segments, facilitating proper alignment and healing during surgical procedures such as ridge augmentation or bone grafting.

The system is supplied as a reusable kit, including screws of varying sizes (e.g., 1.5mm x 7mm and 1.5mm x 8mm) and specialized tools like a bone fix screwdriver and drill bit. It is classified as a Class II medical device under FDA regulations (21 CFR 872.4880) and holds a 510(k) clearance (K161857) for dental use. No specific sterility or MRI safety information is provided in the data.

Frequently asked questions

What types of dental procedures is the Salvin Tenting Screw System intended to support during bone stabilization?

The Salvin Tenting Screw System is designed specifically for intraosseous fixation in dental procedures where bone alignment and stability are critical. This includes applications like ridge augmentation and bone grafting, where screws are used to tent and stabilize bone segments to promote proper alignment and healing.

Are the screws in the Salvin Tenting Screw System single-use or reusable, and how is the kit supplied?

The Salvin Tenting Screw System is supplied as a reusable kit, meaning the screws and tools are intended for multiple uses. The kit includes titanium alloy screws in various sizes (such as 1.5mm x 7mm and 1.5mm x 8mm) along with specialized tools like a bone fix screwdriver and drill bit.

What materials are the screws made of, and how does this affect their use in dental procedures?

The screws in the Salvin Tenting Screw System are made of titanium alloy, a material commonly used in dental implants and fixation devices due to its biocompatibility, strength, and resistance to corrosion. This makes it suitable for intraosseous applications where long-term stability and minimal tissue reaction are desired.

Is there any information provided about the sterility of the Salvin Tenting Screw System, and how should it be stored?

The provided data does not specify any details about the sterility of the Salvin Tenting Screw System or its packaging. Since it is a reusable kit, proper cleaning, sterilization, and storage procedures (such as using sterile packaging or autoclaving) should be followed as per clinical protocols to ensure safety and functionality between uses.

What regulatory pathway was followed for the FDA clearance of the Salvin Tenting Screw System, and what does this mean for its use?

The Salvin Tenting Screw System received FDA clearance through a 510(k) submission, classified as a traditional review under the Dental advisory committee (DE). This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, confirming its safety and effectiveness for the intended dental use as an intraosseous fixation system.

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: Salvin Titanium Tenting Screw, Salvin Tenting Screw Kit With Bone Fix Screwdriver, Salvin Tenting Screw System (K161857) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Salvin Dental Specialties

Sources (1)

  • FDA 510(k) K161857 24 fields · synced Sep 19, 2026