Premium Plus C01/C02 LED Curing Light
K-Number: K153514 · 2016-08-22
ApplicantPremium Plus International Limited
Decision Date2016-08-22
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Premium Plus C01/C02 LED Curing Light is a medical device manufactured by Premium Plus International Limited. It received FDA 510(k) clearance on 2016-08-22 under approval number K153514. 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 Premium Plus C01/C02 LED Curing Light?
Premium Plus C01/C02 LED Curing Light is a medical device that received FDA 510(k) clearance on 2016-08-22. It is manufactured by Premium Plus International Limited. The 510(k) number is K153514.
When was Premium Plus C01/C02 LED Curing Light approved by the FDA?
Premium Plus C01/C02 LED Curing Light received FDA 510(k) clearance on 2016-08-22, under approval number K153514.
What company makes Premium Plus C01/C02 LED Curing Light?
Premium Plus C01/C02 LED Curing Light is manufactured by Premium Plus International Limited.
What is the FDA product code for Premium Plus C01/C02 LED Curing Light?
The FDA product code for Premium Plus C01/C02 LED Curing Light is EBZ.
Related Clinical Trials
Other Devices by Premium Plus International Limited
Related Devices (Code: EBZ)
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.