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FDA 510(k)

D.SIGN 15 (DW286 B)

K-Number: K020898 · 2002-03-29

ApplicantIvoclar Vivadent, Inc.
Decision Date2002-03-29
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

D.SIGN 15 (DW286 B) 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 2002-03-29 under 510(k) number K020898. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the D.SIGN 15 (DW286 B)?

D.SIGN 15 (DW286 B) is a medical device that received FDA 510(k) clearance on 2002-03-29. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K020898.

When did D.SIGN 15 (DW286 B) receive FDA 510(k) clearance?

D.SIGN 15 (DW286 B) received FDA 510(k) clearance on 2002-03-29, under 510(k) number K020898.

Who is the listed applicant for D.SIGN 15 (DW286 B)?

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 15 (DW286 B)?

The FDA product code for D.SIGN 15 (DW286 B) is EJH.

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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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