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FDA 510(k)

BARITONE C2 & BARITONE L3

K-Number: K914322 · 1991-10-23

ApplicantConfi-Dental Products Co.
Decision Date1991-10-23
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BARITONE C2 & BARITONE L3 is the device name listed in this FDA 510(k) record. The listed applicant is Confi-Dental Products Co.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K914322. 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 BARITONE C2 & BARITONE L3?

BARITONE C2 & BARITONE L3 is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Confi-Dental Products Co.. The 510(k) number is K914322.

When did BARITONE C2 & BARITONE L3 receive FDA 510(k) clearance?

BARITONE C2 & BARITONE L3 received FDA 510(k) clearance on 1991-10-23, under 510(k) number K914322.

Who is the listed applicant for BARITONE C2 & BARITONE L3?

The FDA 510(k) record lists Confi-Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARITONE C2 & BARITONE L3?

The FDA product code for BARITONE C2 & BARITONE L3 is EBC.

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Other records listing Confi-Dental Products Co. as applicant

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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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