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Verident Plus, Optiform

by Lactona Corp.

510(k) K940244

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 NumberK940244 Date2 May 1994ClearedStatusActive

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  • Withdrawn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
ELM
Device Class
Class II
Regulation
21 CFR Part 872.3590
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.

Verident Plus and Optiform are plastic denture teeth used in dental applications. These devices are classified as denture, plastic, teeth.

This device is regulated under FDA 510(k) clearance K940244. It is categorized as a Class 2 medical device under the dental medical specialty.

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 are Verident Plus and Optiform devices used for?

    These devices are plastic denture teeth intended for use in dental applications to restore or replace natural teeth within a dental prosthesis.

  • How are these devices regulated?

    Verident Plus and Optiform are classified as Class 2 medical devices under the dental medical specialty and are regulated under FDA 510(k) clearance number K940244.

  • Who is the manufacturer of these denture teeth?

    These devices are manufactured by Lactona Corp., located in Montgomeryville, Pennsylvania.