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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 a medical device manufactured by Dci International, LLC. It received FDA 510(k) clearance on 2025-02-19 under approval 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. It is manufactured by Dci International, LLC. The 510(k) number is K250473.

When was Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus approved by the FDA?

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

What company makes 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 manufactured by Dci International, LLC.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

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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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