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FDA 510(k)

Dental unit Model: Mare

K-Number: K231845 · 2024-02-28

ApplicantFoshan Safety Medical Equipment Co., Ltd.
Decision Date2024-02-28
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental unit Model: Mare is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Safety Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-02-28 under 510(k) number K231845. 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 Dental unit Model: Mare?

Dental unit Model: Mare is a medical device that received FDA 510(k) clearance on 2024-02-28. The listed applicant is Foshan Safety Medical Equipment Co., Ltd.. The 510(k) number is K231845.

When did Dental unit Model: Mare receive FDA 510(k) clearance?

Dental unit Model: Mare received FDA 510(k) clearance on 2024-02-28, under 510(k) number K231845.

Who is the listed applicant for Dental unit Model: Mare?

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

What is the FDA product code for Dental unit Model: Mare?

The FDA product code for Dental unit Model: Mare is EIA.

Related Clinical Trials

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.

NCT07707063This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis PatientsRECRUITING

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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