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FDA 510(k)

SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT

K-Number: K931857 · 1993-07-22

ApplicantConfi-Dental Products Co.
Decision Date1993-07-22
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT 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 1993-07-22 under 510(k) number K931857. 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 SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT?

SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Confi-Dental Products Co.. The 510(k) number is K931857.

When did SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT receive FDA 510(k) clearance?

SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT received FDA 510(k) clearance on 1993-07-22, under 510(k) number K931857.

Who is the listed applicant for SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT?

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 SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT?

The FDA product code for SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT 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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