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New Light-Curing Impression Material

by Dentsply Intl.

510(k) K862879

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 NumberK862879 Date25 Sep 1986ClearedStatusActive

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  • Withdrawn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
ELW
Device Class
Class II
Regulation
21 CFR Part 872.3660
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 New Light-Curing Impression Material is a dental impression material used to capture the anatomy of the oral cavity. It is designed to be cured using a light source to achieve its final set.

This device is classified as a Class 2 dental material under regulation 872.3660. It has received FDA 510(k) clearance via the traditional pathway.

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Questions

AI-generated answers, 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.

  • What is the primary purpose of this impression material?

    This material is used in dental procedures to capture the anatomy of the oral cavity, providing a detailed impression for clinical use.

  • How does the material achieve its final set?

    The material is designed to be cured using an external light source, which triggers the setting process to finalize the impression.

  • What is the regulatory classification of this device?

    This device is classified as a Class 2 dental material under regulation 872.3660 and has received FDA 510(k) clearance via the traditional pathway.