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FDA 510(k)

ORALLITE COMPREHENSIVE EXAM TRAY

K-Number: K012070 · 2001-11-27

ApplicantTrylon Corp.
Decision Date2001-11-27
Product CodeMPU
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ORALLITE COMPREHENSIVE EXAM TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Trylon Corp.. It received FDA 510(k) clearance on 2001-11-27 under 510(k) number K012070. The device is classified under product code MPU. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORALLITE COMPREHENSIVE EXAM TRAY?

ORALLITE COMPREHENSIVE EXAM TRAY is a medical device that received FDA 510(k) clearance on 2001-11-27. The listed applicant is Trylon Corp.. The 510(k) number is K012070.

When did ORALLITE COMPREHENSIVE EXAM TRAY receive FDA 510(k) clearance?

ORALLITE COMPREHENSIVE EXAM TRAY received FDA 510(k) clearance on 2001-11-27, under 510(k) number K012070.

Who is the listed applicant for ORALLITE COMPREHENSIVE EXAM TRAY?

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 ORALLITE COMPREHENSIVE EXAM TRAY?

The FDA product code for ORALLITE COMPREHENSIVE EXAM TRAY is MPU.

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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 INSTRUMENTK003995SPECULITE/ORALLITEK963391SPECULITEK955790PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAYK953364SPECULITE

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Related Devices (Code: MPU)

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.

K963391SPECULITETrylon Corp.

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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