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FDA 510(k)

STUDIO UNO

K-Number: K894061 · 1989-11-21

ApplicantEurodent, Inc.
Decision Date1989-11-21
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STUDIO UNO is the device name listed in this FDA 510(k) record. The listed applicant is Eurodent, Inc.. It received FDA 510(k) clearance on 1989-11-21 under 510(k) number K894061. 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 STUDIO UNO?

STUDIO UNO is a medical device that received FDA 510(k) clearance on 1989-11-21. The listed applicant is Eurodent, Inc.. The 510(k) number is K894061.

When did STUDIO UNO receive FDA 510(k) clearance?

STUDIO UNO received FDA 510(k) clearance on 1989-11-21, under 510(k) number K894061.

Who is the listed applicant for STUDIO UNO?

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

What is the FDA product code for STUDIO UNO?

The FDA product code for STUDIO UNO is EIA.

Related Clinical Trials

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Other records listing Eurodent, Inc. as applicant

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.

K894058ISODENTK894060ESSE QUATTRO/ESSE UNOK894059ISOLIGHTK790078BAR & RIDER, SCREWS, TUBES

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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