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Impregum Penta

by Espe Dental AG 510(k)

Active United States

510(k) K992897

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK992897 Date8 Sep 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

Overview

AI-generated summary, 1 Oct 2026

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

The Impregum Penta is a polyether-based impression material, classified as a dental impression device. It is designed to accurately reproduce the anatomical structure of a patient’s teeth and surrounding oral tissues for use in creating dental prostheses or orthodontic appliances. Its formulation ensures high precision, particularly in complex or moist environments, where traditional materials may fail to maintain accuracy.

This material is supplied in a single-use format and is intended for clinical use by dental professionals. It is non-sterile and requires mixing prior to application. The Impregum Penta is regulated under the FDA’s 510(k) clearance (K992897) as a Class II device under the product code ELW and regulation number 872.3660. It is packaged for dental office use and must be stored according to manufacturer guidelines to maintain its performance characteristics.

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Questions

AI-generated answers, 1 Oct 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 Impregum Penta used for in dental practice?

    The Impregum Penta is a polyether-based dental impression material designed to capture detailed anatomical structures of teeth and surrounding oral tissues. Its formulation ensures high accuracy, particularly in challenging environments like moist areas or complex cases, making it ideal for creating dental prostheses or orthodontic appliances where precision is critical.

  • How is the Impregum Penta supplied and prepared for use?

    The Impregum Penta is supplied in a single-use format, meaning each package is intended for one clinical application. Before use, the material must be mixed according to the manufacturer’s instructions, as it is non-sterile and requires activation prior to application.

  • Is the Impregum Penta sterile or reusable?

    The Impregum Penta is non-sterile and designed for single-use only. It is not intended for reuse, and each package should be discarded after one clinical application to maintain safety and performance standards.

  • What storage conditions are required for the Impregum Penta?

    The Impregum Penta must be stored according to the manufacturer’s guidelines to preserve its performance characteristics. Typically, this includes keeping the material in a cool, dry place, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use.

  • What regulatory clearance does the Impregum Penta hold?

    The Impregum Penta is regulated under the FDA’s 510(k) clearance process, specifically under clearance number K992897. It is classified as a Class II device under product code ELW and regulation number 872.3660, indicating it has been determined substantially equivalent to a predicate device.