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Visio-Band

by Espe-Premier Sales Co. 510(k)

Active United States

510(k) K810265

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810265 Date23 Feb 1981ClearedStatusActive

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  • Withdrawn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
KLE
Device Class
Class II
Regulation
21 CFR Part 872.3200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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-Band is a dental device classified as a tooth bonding resin agent. It is intended for use in dental procedures involving the bonding of restorative materials to tooth structure.

This device is supplied by Espe-Premier Sales Co. and has received FDA 510(k) clearance. It is regulated under the dental specialty and is identified by product code KLE.

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