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FDA 510(k)

WELL-PEX

K-Number: K080266 · 2008-02-06

ApplicantVericom Co., Ltd.
Decision Date2008-02-06
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WELL-PEX is the device name listed in this FDA 510(k) record. The listed applicant is Vericom Co., Ltd.. It received FDA 510(k) clearance on 2008-02-06 under 510(k) number K080266. 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 WELL-PEX?

WELL-PEX is a medical device that received FDA 510(k) clearance on 2008-02-06. The listed applicant is Vericom Co., Ltd.. The 510(k) number is K080266.

When did WELL-PEX receive FDA 510(k) clearance?

WELL-PEX received FDA 510(k) clearance on 2008-02-06, under 510(k) number K080266.

Who is the listed applicant for WELL-PEX?

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

What is the FDA product code for WELL-PEX?

The FDA product code for WELL-PEX is KIF.

Other records listing Vericom Co., Ltd. as applicant

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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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