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Visio-Gem

by Espe GmbH (Us) 510(k)

Active United States

510(k) K833757

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833757 Date3 Feb 1984ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Visio-Gem Art-System is a dental resin-based material used for tooth shade matching and restoration. Classified under product code EBF, it falls under the category of dental materials designed to replicate natural tooth color and structure with precision.

This system is intended for use in dental offices and is supplied as a reusable or single-use kit, depending on the components. The device is regulated under FDA 510(k) clearance (K833757) and is classified as Class II with Special Controls. It adheres to dental standards for shade matching and restoration procedures, ensuring compatibility with standard dental practices.

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