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FDA 510(k)

CHALLENGE-EVER

K-Number: K102223 · 2011-02-25

ApplicantHallim Dentech Co., Ltd.
Decision Date2011-02-25
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHALLENGE-EVER is the device name listed in this FDA 510(k) record. The listed applicant is Hallim Dentech Co., Ltd.. It received FDA 510(k) clearance on 2011-02-25 under 510(k) number K102223. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHALLENGE-EVER?

CHALLENGE-EVER is a medical device that received FDA 510(k) clearance on 2011-02-25. The listed applicant is Hallim Dentech Co., Ltd.. The 510(k) number is K102223.

When did CHALLENGE-EVER receive FDA 510(k) clearance?

CHALLENGE-EVER received FDA 510(k) clearance on 2011-02-25, under 510(k) number K102223.

Who is the listed applicant for CHALLENGE-EVER?

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

What is the FDA product code for CHALLENGE-EVER?

The FDA product code for CHALLENGE-EVER is EIA.

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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