510(k) K250047
K250047 is an FDA 510(k) premarket notification submitted by mibeTec GmbH for the device "bite away two". The FDA issued a decision of Substantially Equivalent on September 12, 2025. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740. mibeTec GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2025
- Date Received
- January 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Heating, Powered
- Device Class
- Class II
- Regulation Number
- 890.5740
- Review Panel
- PM
- Submission Type