Papacarie Duo
K-Number: K233768 · 2024-07-18
ApplicantElevate Oral Care
Decision Date2024-07-18
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Papacarie Duo is a medical device manufactured by Elevate Oral Care. It received FDA 510(k) clearance on 2024-07-18 under approval number K233768. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Papacarie Duo?
Papacarie Duo is a medical device that received FDA 510(k) clearance on 2024-07-18. It is manufactured by Elevate Oral Care. The 510(k) number is K233768.
When was Papacarie Duo approved by the FDA?
Papacarie Duo received FDA 510(k) clearance on 2024-07-18, under approval number K233768.
What company makes Papacarie Duo?
Papacarie Duo is manufactured by Elevate Oral Care.
What is the FDA product code for Papacarie Duo?
The FDA product code for Papacarie Duo is LBH.
Other Devices by Elevate Oral Care
Related Devices (Code: LBH)
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.