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Hydrocolor 5

by Cascades Device Consulting Associates

510(k) K102739

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 NumberK102739 Date8 Dec 2010ClearedStatusActive

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  • Withdrawn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.

Hydrocolor 5 is a conventional alginate dental impression material. It is used by dental professionals and placed on preformed impression trays to capture the anatomical structure of patient teeth.

The material sets to form a negative mold, which is used to create positive dental models for study or fabrication of restorative prosthetics such as inlays and dentures. It is supplied as a material for impression taking and is regulated under FDA 510(k) clearance K102739 with product code ELW and regulation number 872.3660.

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 Hydrocolor 5 used for?

    Hydrocolor 5 is used by dental professionals to capture the anatomical structure of patient teeth by placing it on preformed impression trays, forming a negative mold for creating positive dental models used in study or fabrication of restorative prosthetics such as inlays and dentures.

  • How is Hydrocolor 5 supplied and what is its regulatory status?

    Hydrocolor 5 is supplied as a material for impression taking and is regulated under FDA 510(k) clearance K102739 with product code ELW and regulation number 872.3660, indicating it received traditional clearance as substantially equivalent to a legally marketed device.

  • Is Hydrocolor 5 a single-use or reusable material?

    Hydrocolor 5 is a single-use impression material; after setting, it forms a negative mold that is used to pour a positive model, and the impression itself is not intended for reuse due to material degradation and infection control considerations in dental practice.