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Reversible Hydrocolloid Impression

by Kottler Laboratories 510(k)

Active United States

510(k) K811020

Overview

The REVERSIBLE HYDROCOLLOID IMPRESSION is a dental impression device used in clinics and dental laboratories. It features a reversible hydrocolloid material that allows for easy handling and removal, making it ideal for capturing precise impressions. With its durable design and reliable construction, this device has been recognized as Substantially Equivalent to other similar products.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811020 Date5 May 1981ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
ELW
Device Class
Class II
Regulation
21 CFR Part 872.3660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent