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FDA 510(k)

W-5

K-Number: K022811 · 2002-10-09

ApplicantIvoclar Vivadent, Inc.
Decision Date2002-10-09
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

W-5 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 2002-10-09 under 510(k) number K022811. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the W-5?

W-5 is a medical device that received FDA 510(k) clearance on 2002-10-09. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K022811.

When did W-5 receive FDA 510(k) clearance?

W-5 received FDA 510(k) clearance on 2002-10-09, under 510(k) number K022811.

Who is the listed applicant for W-5?

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 W-5?

The FDA product code for W-5 is EJT.

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Related Devices (Code: EJT)

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.

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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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