FDA 510(k)

bite away two

K-Number: K250047 · 2025-09-12

Decision Date2025-09-12

Product CodeIRT

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

bite away two is the device name listed in this FDA 510(k) record. The listed applicant is mibeTec GmbH. It received FDA 510(k) clearance on 2025-09-12 under 510(k) 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. The listed applicant is mibeTec GmbH. The 510(k) number is K250047.

When did bite away two receive FDA 510(k) clearance?

bite away two received FDA 510(k) clearance on 2025-09-12, under 510(k) number K250047.

Who is the listed applicant for bite away two?

The FDA 510(k) record lists mibeTec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for bite away two?

The FDA product code for bite away two is IRT.

Other records listing mibeTec GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220514bite away neo

Related Devices (Code: IRT)

K220514bite away neomibeTec GmbH K160943Bite AwayRiemser Pharma

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.