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FDA 510(k)

AURALAY PIT & FISSURE SEALANT

K-Number: K071158 · 2007-06-05

ApplicantDenali Corporation
Decision Date2007-06-05
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURALAY PIT & FISSURE SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Denali Corporation. It received FDA 510(k) clearance on 2007-06-05 under 510(k) number K071158. 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 AURALAY PIT & FISSURE SEALANT?

AURALAY PIT & FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 2007-06-05. The listed applicant is Denali Corporation. The 510(k) number is K071158.

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

AURALAY PIT & FISSURE SEALANT received FDA 510(k) clearance on 2007-06-05, under 510(k) number K071158.

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

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

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

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

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Other records listing Denali Corporation 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.

K153191Calcium BridgeK151945Triumph Resin DamK073101AURAVENEER CEMENTK070702FUSION RESIN CEMENT AND CORE KITK070693AURAVUE PIT & FISSURE SEALANT

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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