FUSION Plus Curing Light
K-Number: K180065 · 2019-04-19
ApplicantDentlight, Inc.
Decision Date2019-04-19
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
FUSION Plus Curing Light is a medical device manufactured by Dentlight, Inc.. It received FDA 510(k) clearance on 2019-04-19 under approval 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. It is manufactured by Dentlight, Inc.. The 510(k) number is K180065.
When was FUSION Plus Curing Light approved by the FDA?
FUSION Plus Curing Light received FDA 510(k) clearance on 2019-04-19, under approval number K180065.
What company makes FUSION Plus Curing Light?
FUSION Plus Curing Light is manufactured by Dentlight, Inc..
What is the FDA product code for FUSION Plus Curing Light?
The FDA product code for FUSION Plus Curing Light is 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.