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FDA 510(k)

ASCENT PIT & FISSURE SEALANT

K-Number: K053089 · 2005-12-20

ApplicantCAO Group, Inc.
Decision Date2005-12-20
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ASCENT PIT & FISSURE SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is CAO Group, Inc.. It received FDA 510(k) clearance on 2005-12-20 under 510(k) number K053089. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCENT PIT & FISSURE SEALANT?

ASCENT PIT & FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 2005-12-20. The listed applicant is CAO Group, Inc.. The 510(k) number is K053089.

When did ASCENT PIT & FISSURE SEALANT receive FDA 510(k) clearance?

ASCENT PIT & FISSURE SEALANT received FDA 510(k) clearance on 2005-12-20, under 510(k) number K053089.

Who is the listed applicant for ASCENT PIT & FISSURE SEALANT?

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

What is the FDA product code for ASCENT PIT & FISSURE SEALANT?

The FDA product code for ASCENT PIT & FISSURE SEALANT is EBC.

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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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