← Back to catalogue

Fastray LC

FDA 510(k)

Class II (US FDA 510(k))

510(k) K991631

by Harry J. Bosworth Co.

Identifiers

510(k) Number
K991631 FDA 510(k)
FDA Product Code
ELW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3660 FDA 510(k)
Regulation Number
872.3660 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Fastray LC is a light-cured custom tray material, designed for dental impression procedures. It is formulated as a single-component system supplied in pre-formed sheets, intended to create accurate and stable impression trays for dental casts. This material is engineered to minimize distortion and adhesion to fingers or models when used with an appropriate separator.

Fastray LC is supplied in pre-formed sheets, requiring no additional mixing or preparation beyond application of a separator. It is intended for single-use in dental settings and is classified as a Class II medical device under FDA regulations (872.3660). The material is light-cured, ensuring precise curing and consistent performance. No specific sterility or MRI safety information is provided in the regulatory data, and the device is not intended for reusable applications.

Frequently asked questions

What is the Fastray LC used for in dental procedures?

The Fastray LC is a light-cured custom tray material designed specifically for dental impression procedures. It creates accurate and stable impression trays for dental casts, ensuring precise replication of oral structures. Its formulation helps reduce distortion and minimizes adhesion to fingers or models when used with an appropriate separator.

How is the Fastray LC supplied and prepared for use?

Fastray LC is supplied in pre-formed sheets, eliminating the need for additional mixing or preparation beyond applying a separator. This simplifies the workflow, as users only need to position the sheet and cure it with light, ensuring consistent and reliable results.

Is the Fastray LC intended for single-use or reusable applications?

The Fastray LC is explicitly designed for single-use in dental settings. Its formulation and regulatory classification as a Class II medical device support this intended use, ensuring patient safety and hygiene standards are met.

What distinguishes the Fastray LC from other dental tray materials?

Fastray LC is distinguished by its light-cured formulation, which provides precise curing and minimizes distortion during use. Unlike some materials that require mixing or multi-step preparation, Fastray LC comes pre-formed in sheets, reducing potential errors and simplifying the impression-tray creation process.

Are there any specific storage requirements for Fastray LC?

While the provided data does not specify detailed storage instructions, light-cured materials like Fastray LC are generally best stored in a cool, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the material retains its intended properties and performance for accurate dental impressions.

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: Bosworth Fastray LC - BEUDAMED, PDF Fastray-LC-061914 - dentistry.ouhsc.edu, BOSWORTH FASTRAY™ LC - empiredentalsupplies.com, FASTRAY LC (Bosworth) — Orange and Los Angeles County | Genuine Dental ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Harry J. Bosworth Co.

Sources (1)

  • FDA 510(k) K991631 24 fields · synced Oct 6, 2026