AcceleDent Aura
K-Number: K153048 · 2016-07-08
ApplicantOrthoaccel Technologies, Inc.
Decision Date2016-07-08
Product CodeOYH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
AcceleDent Aura is a medical device manufactured by Orthoaccel Technologies, Inc.. It received FDA 510(k) clearance on 2016-07-08 under approval number K153048. The device is classified under product code OYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AcceleDent Aura?
AcceleDent Aura is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Orthoaccel Technologies, Inc.. The 510(k) number is K153048.
When was AcceleDent Aura approved by the FDA?
AcceleDent Aura received FDA 510(k) clearance on 2016-07-08, under approval number K153048.
What company makes AcceleDent Aura?
AcceleDent Aura is manufactured by Orthoaccel Technologies, Inc..
What is the FDA product code for AcceleDent Aura?
The FDA product code for AcceleDent Aura is OYH.
Related Devices (Code: OYH)
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.