Inspire ICE aka Inspire ICE Clear Brackets
K-Number: K171844 · 2017-07-18
ApplicantOrmco Corporation
Decision Date2017-07-18
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Inspire ICE aka Inspire ICE Clear Brackets is a medical device manufactured by Ormco Corporation. It received FDA 510(k) clearance on 2017-07-18 under approval number K171844. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Inspire ICE aka Inspire ICE Clear Brackets?
Inspire ICE aka Inspire ICE Clear Brackets is a medical device that received FDA 510(k) clearance on 2017-07-18. It is manufactured by Ormco Corporation. The 510(k) number is K171844.
When was Inspire ICE aka Inspire ICE Clear Brackets approved by the FDA?
Inspire ICE aka Inspire ICE Clear Brackets received FDA 510(k) clearance on 2017-07-18, under approval number K171844.
What company makes Inspire ICE aka Inspire ICE Clear Brackets?
Inspire ICE aka Inspire ICE Clear Brackets is manufactured by Ormco Corporation.
What is the FDA product code for Inspire ICE aka Inspire ICE Clear Brackets?
The FDA product code for Inspire ICE aka Inspire ICE Clear Brackets is NJM.
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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.