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FDA 510(k)

MICROLUX TRANSILLUMINATOR

K-Number: K062961 · 2007-02-08

ApplicantAddent, Inc.
Decision Date2007-02-08
Product CodeNTK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICROLUX TRANSILLUMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Addent, Inc.. It received FDA 510(k) clearance on 2007-02-08 under 510(k) number K062961. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROLUX TRANSILLUMINATOR?

MICROLUX TRANSILLUMINATOR is a medical device that received FDA 510(k) clearance on 2007-02-08. The listed applicant is Addent, Inc.. The 510(k) number is K062961.

When did MICROLUX TRANSILLUMINATOR receive FDA 510(k) clearance?

MICROLUX TRANSILLUMINATOR received FDA 510(k) clearance on 2007-02-08, under 510(k) number K062961.

Who is the listed applicant for MICROLUX TRANSILLUMINATOR?

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

What is the FDA product code for MICROLUX TRANSILLUMINATOR?

The FDA product code for MICROLUX TRANSILLUMINATOR is NTK.

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Other records listing Addent, 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.

K182017Compex HDK121282MICROLUX/DL MICROLUX/BLU BIO/SCREENK082668BIO-SCREENK072309MICROLUX/BLUK061395CALSET COMPOSITE HEATERK041614MICROLUX DL

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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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