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FDA 510(k)

FUSION Plus Curing Light

K-Number: K180065 · 2019-04-19

Decision Date2019-04-19
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FUSION Plus Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Dentlight, Inc.. It received FDA 510(k) clearance on 2019-04-19 under 510(k) number K180065. 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 FUSION Plus Curing Light?

FUSION Plus Curing Light is a medical device that received FDA 510(k) clearance on 2019-04-19. The listed applicant is Dentlight, Inc.. The 510(k) number is K180065.

When did FUSION Plus Curing Light receive FDA 510(k) clearance?

FUSION Plus Curing Light received FDA 510(k) clearance on 2019-04-19, under 510(k) number K180065.

Who is the listed applicant for FUSION Plus Curing Light?

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

What is the FDA product code for FUSION Plus Curing Light?

The FDA product code for FUSION Plus Curing Light is EBZ.

Other records listing Dentlight, 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.

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.

Official Source

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