Twilite Appliance
K-Number: K190687 · 2019-07-02
ApplicantStephen J Harkins, Dds, PC
Decision Date2019-07-02
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Twilite Appliance is a medical device manufactured by Stephen J Harkins, Dds, PC. It received FDA 510(k) clearance on 2019-07-02 under approval number K190687. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Twilite Appliance?
Twilite Appliance is a medical device that received FDA 510(k) clearance on 2019-07-02. It is manufactured by Stephen J Harkins, Dds, PC. The 510(k) number is K190687.
When was Twilite Appliance approved by the FDA?
Twilite Appliance received FDA 510(k) clearance on 2019-07-02, under approval number K190687.
What company makes Twilite Appliance?
Twilite Appliance is manufactured by Stephen J Harkins, Dds, PC.
What is the FDA product code for Twilite Appliance?
The FDA product code for Twilite Appliance is LRK.
Related Devices (Code: LRK)
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.