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Zeon Composite Resin Light Cure Sys

by National Patent Development Corp.

510(k) K820028

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820028 Date11 Mar 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 20 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 Zeon Composite Resin Light Cure System is a dental device classified under product code EBF, designed for the restoration of dental cavities. It consists of composite resin materials that are cured using light activation, enabling precise filling of tooth structures while maintaining aesthetic and functional integrity. This system is intended for use in direct restorative procedures, providing durable and natural-looking dental fillings.

The system is supplied as a reusable dental instrument set, intended for use in clinical dental settings. It is not described as sterile or single-use in the regulatory data. The device received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent to the predicate device. No additional details on MRI safety, storage conditions, or specific sizes are provided in the available data.

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