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FDA 510(k)

PREVENT SEAL

K-Number: K122521 · 2013-06-11

ApplicantItena Clinical
Decision Date2013-06-11
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREVENT SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Itena Clinical. It received FDA 510(k) clearance on 2013-06-11 under 510(k) number K122521. 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 PREVENT SEAL?

PREVENT SEAL is a medical device that received FDA 510(k) clearance on 2013-06-11. The listed applicant is Itena Clinical. The 510(k) number is K122521.

When did PREVENT SEAL receive FDA 510(k) clearance?

PREVENT SEAL received FDA 510(k) clearance on 2013-06-11, under 510(k) number K122521.

Who is the listed applicant for PREVENT SEAL?

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

What is the FDA product code for PREVENT SEAL?

The FDA product code for PREVENT SEAL is EBC.

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Other records listing Itena Clinical 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.

K170207ObturysK162960TotalC-RamK122551PROVITEMPK122549DENTO TEMPK121804PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEMK122522DENTOETCH QUICKBOND BOND ACTIVATOR

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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

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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