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FDA 510(k)

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

K-Number: K250473 · 2025-02-19

ApplicantDci International, LLC
Decision Date2025-02-19
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Dci International, LLC. It received FDA 510(k) clearance on 2025-02-19 under 510(k) number K250473. 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 Delivery System Series 5 and Dental Delivery System Series 5 Plus?

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Dci International, LLC. The 510(k) number is K250473.

When did Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus receive FDA 510(k) clearance?

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus received FDA 510(k) clearance on 2025-02-19, under 510(k) number K250473.

Who is the listed applicant for Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus?

The FDA 510(k) record lists Dci International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus?

The FDA product code for Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus 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.K242404BDC Dental UnitBdc Dental Corporation , Ltd.

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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