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D-Sign III (R&D Project DW264#7)

by Ivoclar North America, Inc.

510(k) K990077

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 NumberK990077 Date12 Feb 1999ClearedStatusActive

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  • Withdrawn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
EJS
Device Class
Class II
Regulation
21 CFR Part 872.3060
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 device is an alloy of other noble metal, classified under product code EJS and regulation number 872.3060, as determined by the FDA. It was found substantially equivalent to a legally marketed predicate device through a traditional 510(k) clearance process.

The device was manufactured by Ivoclar North America, Inc. at 175 Pineview Dr., Amherst, NY 14228. It received FDA 510(k) clearance under K990077 on February 12, 1999, following a submission received on January 11, 1999. The device is intended for dental use, as indicated by the advisory committee classification and medical specialty description.

Other devices from Ivoclar North America, Inc.

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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 D-SIGN III (R&D PROJECT DW264#7) device used for?

    The D-SIGN III (R&D PROJECT DW264#7) is intended for dental use, as indicated by its advisory committee classification and medical specialty description, making it suitable for applications requiring an alloy of other noble metal in dental procedures.

  • How was the D-SIGN III (R&D PROJECT DW264#7) cleared for market release?

    The device received FDA 510(k) clearance under K990077 on February 12, 1999, following a traditional 510(k) submission received on January 11, 1999, and was determined to be substantially equivalent to a legally marketed predicate device.

  • Who manufactures the D-SIGN III (R&D PROJECT DW264#7) and where is it produced?

    The D-SIGN III (R&D PROJECT DW264#7) is manufactured by Ivoclar North America, Inc. at their facility located at 175 Pineview Dr., Amherst, NY 14228, United States.