Ultra SEP
K-Number: K210945 · 2021-07-08
ApplicantReliance Orthodontic Products, Inc.
Decision Date2021-07-08
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Ultra SEP is a medical device manufactured by Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2021-07-08 under approval number K210945. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ultra SEP?
Ultra SEP is a medical device that received FDA 510(k) clearance on 2021-07-08. It is manufactured by Reliance Orthodontic Products, Inc.. The 510(k) number is K210945.
When was Ultra SEP approved by the FDA?
Ultra SEP received FDA 510(k) clearance on 2021-07-08, under approval number K210945.
What company makes Ultra SEP?
Ultra SEP is manufactured by Reliance Orthodontic Products, Inc..
What is the FDA product code for Ultra SEP?
The FDA product code for Ultra SEP is KLE.
Other Devices by Reliance Orthodontic Products, Inc.
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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.