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FDA 510(k)

BIOUNIVERSAL PDF

K-Number: K011022 · 2001-05-02

ApplicantIvoclar North America, Inc.
Decision Date2001-05-02
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOUNIVERSAL PDF 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 2001-05-02 under 510(k) number K011022. 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 PDF?

BIOUNIVERSAL PDF is a medical device that received FDA 510(k) clearance on 2001-05-02. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K011022.

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

BIOUNIVERSAL PDF received FDA 510(k) clearance on 2001-05-02, under 510(k) number K011022.

Who is the listed applicant for BIOUNIVERSAL PDF?

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 BIOUNIVERSAL PDF?

The FDA product code for BIOUNIVERSAL PDF is EJT.

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Other records listing Ivoclar North America, Inc. as applicant

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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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