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FDA 510(k)

COLTOLUX LIGHT METER

K-Number: K950106 · 1995-05-24

ApplicantColtene/Whaledent, Inc.
Decision Date1995-05-24
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTOLUX LIGHT METER is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 1995-05-24 under 510(k) number K950106. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLTOLUX LIGHT METER?

COLTOLUX LIGHT METER is a medical device that received FDA 510(k) clearance on 1995-05-24. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K950106.

When did COLTOLUX LIGHT METER receive FDA 510(k) clearance?

COLTOLUX LIGHT METER received FDA 510(k) clearance on 1995-05-24, under 510(k) number K950106.

Who is the listed applicant for COLTOLUX LIGHT METER?

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

What is the FDA product code for COLTOLUX LIGHT METER?

The FDA product code for COLTOLUX LIGHT METER is EBZ.

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Other records listing Coltene/Whaledent, 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.

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Related Devices (Code: EBZ)

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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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