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FDA 510(k)

ISOLIGHT

K-Number: K894059 · 1989-09-07

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

Device Summary

ISOLIGHT 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 K894059. The device is classified under product code EAZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLIGHT?

ISOLIGHT 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 K894059.

When did ISOLIGHT receive FDA 510(k) clearance?

ISOLIGHT received FDA 510(k) clearance on 1989-09-07, under 510(k) number K894059.

Who is the listed applicant for ISOLIGHT?

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 ISOLIGHT?

The FDA product code for ISOLIGHT is EAZ.

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 UNOK894060ESSE QUATTRO/ESSE UNOK790078BAR & RIDER, SCREWS, TUBES

Related Devices (Code: EAZ)

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.

K072309MICROLUX/BLUAddent, Inc.K041614MICROLUX DLAddent, Inc.K033033VIZILITE-BLUE ORAL EXAM KITTrylon Corp.K003995SPECULITE/ORALLITETrylon Corp.K926081DENTAL LIGHTMdt Corp., Inc.K935390SIROLUX FANTASTICPelton & Crane Co.

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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