bite away two
K-Number: K250047 · 2025-09-12
ApplicantmibeTec GmbH
Decision Date2025-09-12
Product CodeIRT
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
bite away two is a medical device manufactured by mibeTec GmbH. It received FDA 510(k) clearance on 2025-09-12 under approval number K250047. The device is classified under product code IRT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the bite away two?
bite away two is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by mibeTec GmbH. The 510(k) number is K250047.
When was bite away two approved by the FDA?
bite away two received FDA 510(k) clearance on 2025-09-12, under approval number K250047.
What company makes bite away two?
bite away two is manufactured by mibeTec GmbH.
What is the FDA product code for bite away two?
The FDA product code for bite away two is IRT.
Other Devices by mibeTec GmbH
Related Devices (Code: IRT)
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.