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FDA 510(k)

VIZILITE-BLUE ORAL EXAM KIT

K-Number: K033033 · 2004-11-22

ApplicantTrylon Corp.
Decision Date2004-11-22
Product CodeEAZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VIZILITE-BLUE ORAL EXAM KIT is the device name listed in this FDA 510(k) record. The listed applicant is Trylon Corp.. It received FDA 510(k) clearance on 2004-11-22 under 510(k) number K033033. 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 VIZILITE-BLUE ORAL EXAM KIT?

VIZILITE-BLUE ORAL EXAM KIT is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is Trylon Corp.. The 510(k) number is K033033.

When did VIZILITE-BLUE ORAL EXAM KIT receive FDA 510(k) clearance?

VIZILITE-BLUE ORAL EXAM KIT received FDA 510(k) clearance on 2004-11-22, under 510(k) number K033033.

Who is the listed applicant for VIZILITE-BLUE ORAL EXAM KIT?

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

What is the FDA product code for VIZILITE-BLUE ORAL EXAM KIT?

The FDA product code for VIZILITE-BLUE ORAL EXAM KIT is EAZ.

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Other records listing Trylon Corp. 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.

K011488SPIRABRUSH CX BIOPSY INSTRUMENTK012070ORALLITE COMPREHENSIVE EXAM TRAYK003995SPECULITE/ORALLITEK963391SPECULITEK955790PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAYK953364SPECULITE

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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.K003995SPECULITE/ORALLITETrylon Corp.K926081DENTAL LIGHTMdt Corp., Inc.K935390SIROLUX FANTASTICPelton & Crane Co.K925629ACCESSORY TO IMPROVED DENTAL OPERATING LIGHTDen-Tal-Ez Mfg Co., Inc.

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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