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FDA 510(k)

FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS

K-Number: K890494 · 1989-03-29

ApplicantMacrochem Corp.
Decision Date1989-03-29
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS is the device name listed in this FDA 510(k) record. The listed applicant is Macrochem Corp.. It received FDA 510(k) clearance on 1989-03-29 under 510(k) number K890494. 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 FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS?

FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS is a medical device that received FDA 510(k) clearance on 1989-03-29. The listed applicant is Macrochem Corp.. The 510(k) number is K890494.

When did FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS receive FDA 510(k) clearance?

FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS received FDA 510(k) clearance on 1989-03-29, under 510(k) number K890494.

Who is the listed applicant for FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS?

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

What is the FDA product code for FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS?

The FDA product code for FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS is EBC.

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Other records listing Macrochem Corp. 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.

K890623FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENTK890608FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENTK880562ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KITK861546REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT

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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