Orthodontic Screw
K-Number: K161197 · 2016-12-21
ApplicantOsstem Implant Co., Ltd.
Decision Date2016-12-21
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Orthodontic Screw is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2016-12-21 under approval number K161197. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Orthodontic Screw?
Orthodontic Screw is a medical device that received FDA 510(k) clearance on 2016-12-21. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K161197.
When was Orthodontic Screw approved by the FDA?
Orthodontic Screw received FDA 510(k) clearance on 2016-12-21, under approval number K161197.
What company makes Orthodontic Screw?
Orthodontic Screw is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for Orthodontic Screw?
The FDA product code for Orthodontic Screw is OAT.
Related Clinical Trials
Other Devices by Osstem Implant Co., Ltd.
Related Devices (Code: OAT)
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.