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FDA 510(k)

Metapex Plus

K-Number: K202617 · 2021-04-14

ApplicantMeta Biomed Co., Ltd.
Decision Date2021-04-14
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Metapex Plus 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 2021-04-14 under 510(k) number K202617. 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 Plus?

Metapex Plus is a medical device that received FDA 510(k) clearance on 2021-04-14. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K202617.

When did Metapex Plus receive FDA 510(k) clearance?

Metapex Plus received FDA 510(k) clearance on 2021-04-14, under 510(k) number K202617.

Who is the listed applicant for Metapex Plus?

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 Plus?

The FDA product code for Metapex Plus is KIF.

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.

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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.

K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr CorporationK251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.K252285Well-Root PTVericom Co., Ltd.K251884One-Fil Putty InjectableMediclus 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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