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FDA 510(k)

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL

K-Number: K113818 · 2012-03-21

ApplicantPulpdent Corporation
Decision Date2012-03-21
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2012-03-21 under 510(k) number K113818. 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 EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL?

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL is a medical device that received FDA 510(k) clearance on 2012-03-21. The listed applicant is Pulpdent Corporation. The 510(k) number is K113818.

When did EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL receive FDA 510(k) clearance?

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL received FDA 510(k) clearance on 2012-03-21, under 510(k) number K113818.

Who is the listed applicant for EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL?

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

What is the FDA product code for EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL?

The FDA product code for EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL is EBC.

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Other records listing Pulpdent Corporation 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.

K210045ACTIVA PRESTO PACKK173020OBA-MCP, Orthodontic Bracket Adhesive with MCPK172169Pulpdent (Activa) Pit and Fissure Sealant with MCPK153249Pulpdent Solo Flowable Composite with MCPK130223RMGI FILLK123265RMGI LOW VISCOSITY

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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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