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FDA 510(k)

SPECULITE/ORALLITE

K-Number: K003995 · 2001-03-16

ApplicantTrylon Corp.
Decision Date2001-03-16
Product CodeEAZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPECULITE/ORALLITE is the device name listed in this FDA 510(k) record. The listed applicant is Trylon Corp.. It received FDA 510(k) clearance on 2001-03-16 under 510(k) number K003995. 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 SPECULITE/ORALLITE?

SPECULITE/ORALLITE is a medical device that received FDA 510(k) clearance on 2001-03-16. The listed applicant is Trylon Corp.. The 510(k) number is K003995.

When did SPECULITE/ORALLITE receive FDA 510(k) clearance?

SPECULITE/ORALLITE received FDA 510(k) clearance on 2001-03-16, under 510(k) number K003995.

Who is the listed applicant for SPECULITE/ORALLITE?

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 SPECULITE/ORALLITE?

The FDA product code for SPECULITE/ORALLITE 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 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.

K033033VIZILITE-BLUE ORAL EXAM KITK011488SPIRABRUSH CX BIOPSY INSTRUMENTK012070ORALLITE COMPREHENSIVE EXAM TRAYK963391SPECULITEK955790PAP 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.K033033VIZILITE-BLUE ORAL EXAM KITTrylon 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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