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FDA 510(k)

SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT

K-Number: K093059 · 2010-02-04

ApplicantClassone Orthodontics, Inc.
Decision Date2010-02-04
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Classone Orthodontics, Inc.. It received FDA 510(k) clearance on 2010-02-04 under 510(k) number K093059. 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 SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT?

SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 2010-02-04. The listed applicant is Classone Orthodontics, Inc.. The 510(k) number is K093059.

When did SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT receive FDA 510(k) clearance?

SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT received FDA 510(k) clearance on 2010-02-04, under 510(k) number K093059.

Who is the listed applicant for SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT?

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

What is the FDA product code for SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT?

The FDA product code for SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT is EBC.

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Other records listing Classone Orthodontics, 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.

K080445LION SE ONE STEP ORTHODONTIC ADHESIVEK053379RELI-ON ONE STEP, ORTHODONTIC ADHESIVE

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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