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FDA 510(k)

BIOUNIVERSAL PKF

K-Number: K030435 · 2003-04-15

ApplicantIvoclar Vivadent, Inc.
Decision Date2003-04-15
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOUNIVERSAL PKF 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 2003-04-15 under 510(k) number K030435. 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 BIOUNIVERSAL PKF?

BIOUNIVERSAL PKF is a medical device that received FDA 510(k) clearance on 2003-04-15. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K030435.

When did BIOUNIVERSAL PKF receive FDA 510(k) clearance?

BIOUNIVERSAL PKF received FDA 510(k) clearance on 2003-04-15, under 510(k) number K030435.

Who is the listed applicant for BIOUNIVERSAL PKF?

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 BIOUNIVERSAL PKF?

The FDA product code for BIOUNIVERSAL PKF is EJT.

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Related Devices (Code: EJT)

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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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