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FDA 510(k)

COLTOLUX LED CURING LIGHT

K-Number: K040551 · 2004-03-15

ApplicantColtene/Whaledent, Inc.
Decision Date2004-03-15
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTOLUX LED CURING LIGHT 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 2004-03-15 under 510(k) number K040551. 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 LED CURING LIGHT?

COLTOLUX LED CURING LIGHT is a medical device that received FDA 510(k) clearance on 2004-03-15. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K040551.

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

COLTOLUX LED CURING LIGHT received FDA 510(k) clearance on 2004-03-15, under 510(k) number K040551.

Who is the listed applicant for COLTOLUX LED CURING LIGHT?

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 LED CURING LIGHT?

The FDA product code for COLTOLUX LED CURING LIGHT is EBZ.

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Related Devices (Code: EBZ)

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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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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