FDA 510(k)

D-SIGN I (R&D PROJECT DW263 #24)

K-Number: K984451 · 1999-01-19

Decision Date1999-01-19

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

D-SIGN I (R&D PROJECT DW263 #24) is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1999-01-19 under 510(k) number K984451. 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 I (R&D PROJECT DW263 #24)?

D-SIGN I (R&D PROJECT DW263 #24) is a medical device that received FDA 510(k) clearance on 1999-01-19. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K984451.

When did D-SIGN I (R&D PROJECT DW263 #24) receive FDA 510(k) clearance?

D-SIGN I (R&D PROJECT DW263 #24) received FDA 510(k) clearance on 1999-01-19, under 510(k) number K984451.

Who is the listed applicant for D-SIGN I (R&D PROJECT DW263 #24)?

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

What is the FDA product code for D-SIGN I (R&D PROJECT DW263 #24)?

The FDA product code for D-SIGN I (R&D PROJECT DW263 #24) is EJS.

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Other records listing Ivoclar North America, Inc. as applicant

K012174ERIS LAYERING MATERIALS K011491HELIOSEAL CLEAR CHROMA K011492IN TEN-S K011490MODIFICATION TO EXCITE K011023D.SIGN 96 K011022BIOUNIVERSAL PDF

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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.