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FDA 510(k)

Vanguard Dental Unit

K-Number: K161734 · 2016-12-09

ApplicantRitter Concept GmbH
Decision Date2016-12-09
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vanguard Dental Unit is the device name listed in this FDA 510(k) record. The listed applicant is Ritter Concept GmbH. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K161734. 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 Vanguard Dental Unit?

Vanguard Dental Unit is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Ritter Concept GmbH. The 510(k) number is K161734.

When did Vanguard Dental Unit receive FDA 510(k) clearance?

Vanguard Dental Unit received FDA 510(k) clearance on 2016-12-09, under 510(k) number K161734.

Who is the listed applicant for Vanguard Dental Unit?

The FDA 510(k) record lists Ritter Concept GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vanguard Dental Unit?

The FDA product code for Vanguard Dental Unit is EIA.

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.

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, LLCK242404BDC Dental UnitBdc Dental Corporation , Ltd.

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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