AcceleDent Optima
K-Number: K170093 · 2017-05-26
ApplicantOrthoaccel Technology, Inc.
Decision Date2017-05-26
Product CodeOYH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
AcceleDent Optima is a medical device manufactured by Orthoaccel Technology, Inc.. It received FDA 510(k) clearance on 2017-05-26 under approval number K170093. 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 Optima?
AcceleDent Optima is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Orthoaccel Technology, Inc.. The 510(k) number is K170093.
When was AcceleDent Optima approved by the FDA?
AcceleDent Optima received FDA 510(k) clearance on 2017-05-26, under approval number K170093.
What company makes AcceleDent Optima?
AcceleDent Optima is manufactured by Orthoaccel Technology, Inc..
What is the FDA product code for AcceleDent Optima?
The FDA product code for AcceleDent Optima 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.