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FDA 510(k)

TESCERA OPAQUER POWDER/SCULPTING RESIN

K-Number: K042804 · 2005-02-01

ApplicantBisco, Inc.
Decision Date2005-02-01
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TESCERA OPAQUER POWDER/SCULPTING RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2005-02-01 under 510(k) number K042804. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TESCERA OPAQUER POWDER/SCULPTING RESIN?

TESCERA OPAQUER POWDER/SCULPTING RESIN is a medical device that received FDA 510(k) clearance on 2005-02-01. The listed applicant is Bisco, Inc.. The 510(k) number is K042804.

When did TESCERA OPAQUER POWDER/SCULPTING RESIN receive FDA 510(k) clearance?

TESCERA OPAQUER POWDER/SCULPTING RESIN received FDA 510(k) clearance on 2005-02-01, under 510(k) number K042804.

Who is the listed applicant for TESCERA OPAQUER POWDER/SCULPTING RESIN?

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

What is the FDA product code for TESCERA OPAQUER POWDER/SCULPTING RESIN?

The FDA product code for TESCERA OPAQUER POWDER/SCULPTING RESIN is EBF.

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Other records listing Bisco, Inc. as applicant

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Related Devices (Code: EBF)

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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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