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FDA 510(k)

MARE DENTAL OPERATIVE UNIT

K-Number: K041458 · 2004-08-24

ApplicantDenimed Electronica S.H.
Decision Date2004-08-24
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MARE DENTAL OPERATIVE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Denimed Electronica S.H.. It received FDA 510(k) clearance on 2004-08-24 under 510(k) number K041458. 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 MARE DENTAL OPERATIVE UNIT?

MARE DENTAL OPERATIVE UNIT is a medical device that received FDA 510(k) clearance on 2004-08-24. The listed applicant is Denimed Electronica S.H.. The 510(k) number is K041458.

When did MARE DENTAL OPERATIVE UNIT receive FDA 510(k) clearance?

MARE DENTAL OPERATIVE UNIT received FDA 510(k) clearance on 2004-08-24, under 510(k) number K041458.

Who is the listed applicant for MARE DENTAL OPERATIVE UNIT?

The FDA 510(k) record lists Denimed Electronica S.H. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MARE DENTAL OPERATIVE UNIT?

The FDA product code for MARE DENTAL OPERATIVE UNIT 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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