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FDA 510(k)

METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING

K-Number: K032603 · 2003-10-07

ApplicantMeta Biomed Co., Ltd.
Decision Date2003-10-07
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2003-10-07 under 510(k) number K032603. 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 METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING?

METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING is a medical device that received FDA 510(k) clearance on 2003-10-07. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K032603.

When did METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING receive FDA 510(k) clearance?

METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING received FDA 510(k) clearance on 2003-10-07, under 510(k) number K032603.

Who is the listed applicant for METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING?

The FDA 510(k) record lists Meta Biomed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING?

The FDA product code for METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING is KIF.

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Other records listing Meta Biomed Co., Ltd. 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.

K242014Jet Flow BulkK232299CeraPuttyK230010ADSEAL PlusK230009EZ Bond UniversalK210904Metapaste PlusK202617Metapex Plus

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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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