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FDA 510(k)

D.SIGN 84

K-Number: K014042 · 2002-02-22

ApplicantIvoclar Vivadent, Inc.
Decision Date2002-02-22
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

D.SIGN 84 is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2002-02-22 under 510(k) number K014042. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D.SIGN 84?

D.SIGN 84 is a medical device that received FDA 510(k) clearance on 2002-02-22. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K014042.

When did D.SIGN 84 receive FDA 510(k) clearance?

D.SIGN 84 received FDA 510(k) clearance on 2002-02-22, under 510(k) number K014042.

Who is the listed applicant for D.SIGN 84?

The FDA 510(k) record lists Ivoclar Vivadent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D.SIGN 84?

The FDA product code for D.SIGN 84 is EJS.

Other records listing Ivoclar Vivadent, Inc. as applicant

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Related Devices (Code: EJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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