TKO Composite Bite Turbo Gel
K-Number: K210349 · 2021-07-20
ApplicantReliance Orthodontic Products, Inc.
Decision Date2021-07-20
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TKO Composite Bite Turbo Gel is a medical device manufactured by Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2021-07-20 under approval number K210349. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TKO Composite Bite Turbo Gel?
TKO Composite Bite Turbo Gel is a medical device that received FDA 510(k) clearance on 2021-07-20. It is manufactured by Reliance Orthodontic Products, Inc.. The 510(k) number is K210349.
When was TKO Composite Bite Turbo Gel approved by the FDA?
TKO Composite Bite Turbo Gel received FDA 510(k) clearance on 2021-07-20, under approval number K210349.
What company makes TKO Composite Bite Turbo Gel?
TKO Composite Bite Turbo Gel is manufactured by Reliance Orthodontic Products, Inc..
What is the FDA product code for TKO Composite Bite Turbo Gel?
The FDA product code for TKO Composite Bite Turbo Gel is EBF.
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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.