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FDA 510(k)

PULPDENT POST CEMENT

K-Number: K020481 · 2002-04-17

ApplicantPulpdent Corporation
Decision Date2002-04-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT POST CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2002-04-17 under 510(k) number K020481. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT POST CEMENT?

PULPDENT POST CEMENT is a medical device that received FDA 510(k) clearance on 2002-04-17. The listed applicant is Pulpdent Corporation. The 510(k) number is K020481.

When did PULPDENT POST CEMENT receive FDA 510(k) clearance?

PULPDENT POST CEMENT received FDA 510(k) clearance on 2002-04-17, under 510(k) number K020481.

Who is the listed applicant for PULPDENT POST CEMENT?

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 POST CEMENT?

The FDA product code for PULPDENT POST CEMENT is EMA.

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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: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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