tün® ultrasonic tips product family
K-Number: K182145 · 2019-06-07
ApplicantEngineered Endodontics
Decision Date2019-06-07
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
tün® ultrasonic tips product family is a medical device manufactured by Engineered Endodontics. It received FDA 510(k) clearance on 2019-06-07 under approval number K182145. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the tün® ultrasonic tips product family?
tün® ultrasonic tips product family is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Engineered Endodontics. The 510(k) number is K182145.
When was tün® ultrasonic tips product family approved by the FDA?
tün® ultrasonic tips product family received FDA 510(k) clearance on 2019-06-07, under approval number K182145.
What company makes tün® ultrasonic tips product family?
tün® ultrasonic tips product family is manufactured by Engineered Endodontics.
What is the FDA product code for tün® ultrasonic tips product family?
The FDA product code for tün® ultrasonic tips product family is ELC.
Related Devices (Code: ELC)
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.