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FDA 510(k)

ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019

K-Number: K062886 · 2006-11-06

Decision Date2006-11-06
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 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 2006-11-06 under 510(k) number K062886. 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 AND FISSURE SEALANT, MODEL 006-00019?

ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 is a medical device that received FDA 510(k) clearance on 2006-11-06. The listed applicant is CAO Group, Inc.. The 510(k) number is K062886.

When did ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 receive FDA 510(k) clearance?

ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 received FDA 510(k) clearance on 2006-11-06, under 510(k) number K062886.

Who is the listed applicant for ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019?

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 AND FISSURE SEALANT, MODEL 006-00019?

The FDA product code for ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 is EBC.

Related Clinical Trials

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.

Other records listing CAO Group, Inc. as applicant

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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Related Devices (Code: EBC)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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