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DW 236

by Ivoclar North America, Inc.

510(k) K905204

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 NumberK905204 Date29 Mar 1991ClearedStatusActive

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  • Withdrawn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
EJJ
Device Class
Class II
Regulation
21 CFR Part 872.3070
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

DW 236 is an alloy amalgam device used in dental applications. It is classified as a Class II medical device under FDA regulation number 872.3070 and has the product code EJJ.

DW 236 received FDA 510(k) clearance (K905204) on March 29, 1991, following a traditional review process. The device is manufactured by Ivoclar North America, Inc. and is substantially equivalent to a legally marketed predicate device.

Other devices from Ivoclar North America, Inc.

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Questions

AI-generated answers, 6 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 DW 236 device used for?

    The DW 236 is an alloy amalgam device intended for dental applications, specifically used in restorative dentistry for filling cavities due to its durability and sealing properties as a Class II medical device under FDA regulation 872.3070.

  • How is the DW 236 supplied and is it sterile or single-use?

    The DW 236 is supplied as a non-sterile alloy amalgam material in bulk form for dental use; it is not sterile and is intended for single-patient use during a procedure, though the material itself is not discarded until after placement and curing in the tooth.

  • What regulatory pathway was used for the DW 236 and when was it cleared?

    The DW 236 received FDA 510(k) clearance through a traditional review process on March 29, 1991, under K905204, demonstrating substantial equivalence to a legally marketed predicate device in the same class and regulation.