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FDA 510(k)

PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL

K-Number: K081810 · 2008-09-17

ApplicantPulpdent Corporation
Decision Date2008-09-17
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2008-09-17 under 510(k) number K081810. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL?

PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL is a medical device that received FDA 510(k) clearance on 2008-09-17. The listed applicant is Pulpdent Corporation. The 510(k) number is K081810.

When did PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL receive FDA 510(k) clearance?

PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL received FDA 510(k) clearance on 2008-09-17, under 510(k) number K081810.

Who is the listed applicant for PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL?

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 PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL?

The FDA product code for PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL is EBG.

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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: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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