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Denta Plast

by Denta, Inc. 510(k)

Active United States

510(k) K830440

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830440 Date28 Apr 1983ClearedStatusActive

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  • Withdrawn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
EMA
Device Class
Class II
Regulation
21 CFR Part 872.3275
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Denta Plast is a dental cement, classified as a Class II medical device under FDA regulations. It is designed for use in dental procedures to provide adhesive bonding and structural support within the oral cavity, typically in restorative or prosthetic applications.

This device is supplied in multiple registration numbers and is intended for single-use or reusable applications depending on the specific formulation and clinical setting. It is regulated under the FDA’s 510(k) pathway with a traditional clearance process, adhering to the requirements outlined in regulation number 872.3275. The device is manufactured by Denta, Inc. and must be handled in accordance with standard dental practice guidelines.

Other devices from Denta, Inc.

  • Denta A-33

    Class I