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FDA 510(k)

PULPDENT CALCIUM HYDROXIDE PREPARATION

K-Number: K022734 · 2002-10-07

ApplicantPulpdent Corporation
Decision Date2002-10-07
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT CALCIUM HYDROXIDE PREPARATION is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2002-10-07 under 510(k) number K022734. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT CALCIUM HYDROXIDE PREPARATION?

PULPDENT CALCIUM HYDROXIDE PREPARATION is a medical device that received FDA 510(k) clearance on 2002-10-07. The listed applicant is Pulpdent Corporation. The 510(k) number is K022734.

When did PULPDENT CALCIUM HYDROXIDE PREPARATION receive FDA 510(k) clearance?

PULPDENT CALCIUM HYDROXIDE PREPARATION received FDA 510(k) clearance on 2002-10-07, under 510(k) number K022734.

Who is the listed applicant for PULPDENT CALCIUM HYDROXIDE PREPARATION?

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 CALCIUM HYDROXIDE PREPARATION?

The FDA product code for PULPDENT CALCIUM HYDROXIDE PREPARATION is KIF.

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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: KIF)

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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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