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FDA 510(k)

Infinity / Infinity Cross Flex Dental Systems

K-Number: K180935 · 2020-02-05

ApplicantOlsen Industria E Comercio S.A.
Decision Date2020-02-05
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Infinity / Infinity Cross Flex Dental Systems is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Industria E Comercio S.A.. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K180935. 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 Infinity / Infinity Cross Flex Dental Systems?

Infinity / Infinity Cross Flex Dental Systems is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Olsen Industria E Comercio S.A.. The 510(k) number is K180935.

When did Infinity / Infinity Cross Flex Dental Systems receive FDA 510(k) clearance?

Infinity / Infinity Cross Flex Dental Systems received FDA 510(k) clearance on 2020-02-05, under 510(k) number K180935.

Who is the listed applicant for Infinity / Infinity Cross Flex Dental Systems?

The FDA 510(k) record lists Olsen Industria E Comercio S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infinity / Infinity Cross Flex Dental Systems?

The FDA product code for Infinity / Infinity Cross Flex Dental Systems 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.

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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