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Light Cure Dental Adhesive

by Rizhao Huge Biomaterials Company, Ltd.

510(k) K201787

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 NumberK201787 Date25 Sep 2020ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 26 Sep 2026

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

Light Cure Dental Adhesive is an agent used for tooth bonding, classified as a resin-based dental material. It is a device intended for use in dental procedures to bond restorative materials to tooth structure.

The device is supplied as a dental adhesive and is regulated under FDA 510(k) clearance K201787. It is classified as a Class II medical device with product code KLE and regulation number 872.3200, and is manufactured by Rizhao Huge Biomaterials Company, Ltd. in Rizhao City, China.

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