FDA 510(k)

D.SIGN 53, MODEL NA1012204

K-Number: K014082 · 2002-01-30

Decision Date2002-01-30

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

D.SIGN 53, MODEL NA1012204 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 2002-01-30 under 510(k) number K014082. 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 53, MODEL NA1012204?

D.SIGN 53, MODEL NA1012204 is a medical device that received FDA 510(k) clearance on 2002-01-30. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K014082.

When did D.SIGN 53, MODEL NA1012204 receive FDA 510(k) clearance?

D.SIGN 53, MODEL NA1012204 received FDA 510(k) clearance on 2002-01-30, under 510(k) number K014082.

Who is the listed applicant for D.SIGN 53, MODEL NA1012204?

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 53, MODEL NA1012204?

The FDA product code for D.SIGN 53, MODEL NA1012204 is EJS.

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Other records listing Ivoclar Vivadent, Inc. as applicant

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Related Devices (Code: EJS)

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG K022252STERNGOLD 1, MODEL 1127781Sterngold K022469ECO E4Wieland Dental + Technik GmbH & Co. KG K021367STERNGOLD 66, MODEL #1180230Sterngold K020195SIMIDUR 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.