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Vonflex S Bite

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140966

by Vericom Co., Ltd.

Identifiers

510(k) Number
K140966 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)

Vonflex S Bite is a thixotropic bite registration material used in dental procedures to capture and reproduce a patient's occlusion between the upper and lower teeth. It is designed to register bite information, often used in conjunction with bite forks or needle-point registrations to create accurate dental models.

The material is supplied in 50 ml cartridges and includes bite fork tips. It is intended for single-use applications and should be stored according to the manufacturer's instructions. The device is regulated under FDA 510(k) clearance and is classified as a Class II medical device.

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: Product - VERICOM Co., Ltd., Vericom - Vonflex S Bite - UDS Dental, Vericom Vonflex S Bite Closing Recording Material 2*50 ml

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vericom Co., Ltd.

Sources (1)

  • FDA 510(k) K140966 24 fields · synced Sep 24, 2026