Skip to content

Correct Plus 1

by Pentron Clinical

510(k) K130920

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 NumberK130920 Date2 Jul 2013ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

Correct Plus 1 is a dental impression material. It is a vinyl polysiloxane impression material designed to accommodate all impression techniques.

It is supplied as a material for dental impressions and is regulated under FDA 510(k) clearance K130920. The device is classified as a Class II medical device with product code ELW and regulation number 872.3660.

Other devices from Pentron Clinical

Questions

AI-generated answers, 24 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 Correct Plus 1 used for?

    Correct Plus 1 is a dental impression material designed to accommodate all impression techniques, made from vinyl polysiloxane for use in dental procedures requiring accurate molds of teeth and oral structures.

  • How is Correct Plus 1 supplied and is it sterile or single-use?

    Correct Plus 1 is supplied as a dental impression material; the provided data does not specify sterility or single-use status, so users should consult the manufacturer's labeling for details on handling, sterility, and reuse limitations.

  • What regulatory clearance does Correct Plus 1 have and what is its classification?

    Correct Plus 1 has FDA 510(k) clearance under K130920, is classified as a Class II medical device with product code ELW, and is regulated under 21 CFR 872.3660 for dental impression materials.