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FDA 510(k)

DYRACT SEAL COMPOMER PIT & FISSURE SEALANT

K-Number: K992516 · 1999-08-27

ApplicantDentsply Intl.
Decision Date1999-08-27
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DYRACT SEAL COMPOMER PIT & FISSURE SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1999-08-27 under 510(k) number K992516. 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 DYRACT SEAL COMPOMER PIT & FISSURE SEALANT?

DYRACT SEAL COMPOMER PIT & FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 1999-08-27. The listed applicant is Dentsply Intl.. The 510(k) number is K992516.

When did DYRACT SEAL COMPOMER PIT & FISSURE SEALANT receive FDA 510(k) clearance?

DYRACT SEAL COMPOMER PIT & FISSURE SEALANT received FDA 510(k) clearance on 1999-08-27, under 510(k) number K992516.

Who is the listed applicant for DYRACT SEAL COMPOMER PIT & FISSURE SEALANT?

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

What is the FDA product code for DYRACT SEAL COMPOMER PIT & FISSURE SEALANT?

The FDA product code for DYRACT SEAL COMPOMER PIT & FISSURE SEALANT is EBC.

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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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