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FDA 510(k)

ESSE QUATTRO/ESSE UNO

K-Number: K894060 · 1989-09-07

ApplicantEurodent, Inc.
Decision Date1989-09-07
Product CodeKLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESSE QUATTRO/ESSE 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 1989-09-07 under 510(k) number K894060. The device is classified under product code KLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESSE QUATTRO/ESSE UNO?

ESSE QUATTRO/ESSE UNO is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Eurodent, Inc.. The 510(k) number is K894060.

When did ESSE QUATTRO/ESSE UNO receive FDA 510(k) clearance?

ESSE QUATTRO/ESSE UNO received FDA 510(k) clearance on 1989-09-07, under 510(k) number K894060.

Who is the listed applicant for ESSE QUATTRO/ESSE 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 ESSE QUATTRO/ESSE UNO?

The FDA product code for ESSE QUATTRO/ESSE UNO is KLC.

Related Clinical Trials

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.

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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.

K894058ISODENTK894061STUDIO UNOK894059ISOLIGHTK790078BAR & RIDER, SCREWS, TUBES

Related Devices (Code: KLC)

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.

K233921Luvis Chair (LC700C)Dentis Co., Ltd.K151987DCI Edge Dental Chair with Operative UnitDciK071353FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48CShanghai Foshion Medical Instruments Co., Ltd.K971063OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIRKing Dental Corp.K963209PROSTYLE COMPACTPlanmeca OyK942870ULTIMA 2 DENTAL CHAIRDentech Corp.

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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