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FDA 510(k)

Nanova Sealant

K-Number: K171330 · 2017-09-08

ApplicantNanova Biomaterials, Inc.
Decision Date2017-09-08
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nanova Sealant is the device name listed in this FDA 510(k) record. The listed applicant is Nanova Biomaterials, Inc.. It received FDA 510(k) clearance on 2017-09-08 under 510(k) number K171330. 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 Nanova Sealant?

Nanova Sealant is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Nanova Biomaterials, Inc.. The 510(k) number is K171330.

When did Nanova Sealant receive FDA 510(k) clearance?

Nanova Sealant received FDA 510(k) clearance on 2017-09-08, under 510(k) number K171330.

Who is the listed applicant for Nanova Sealant?

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

What is the FDA product code for Nanova Sealant?

The FDA product code for Nanova Sealant is EBC.

Other records listing Nanova Biomaterials, 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.

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

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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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