Bioliner
K-Number: K182658 · 2019-06-19
ApplicantFive Star Orthodontic Lab & Supply
Decision Date2019-06-19
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bioliner is a medical device manufactured by Five Star Orthodontic Lab & Supply. It received FDA 510(k) clearance on 2019-06-19 under approval number K182658. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bioliner?
Bioliner is a medical device that received FDA 510(k) clearance on 2019-06-19. It is manufactured by Five Star Orthodontic Lab & Supply. The 510(k) number is K182658.
When was Bioliner approved by the FDA?
Bioliner received FDA 510(k) clearance on 2019-06-19, under approval number K182658.
What company makes Bioliner?
Bioliner is manufactured by Five Star Orthodontic Lab & Supply.
What is the FDA product code for Bioliner?
The FDA product code for Bioliner is NXC.
Related Devices (Code: NXC)
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.