510(k) K241226
K241226 is an FDA 510(k) premarket notification submitted by Dreve Denatmid GmbH for the device "Fixtemp® C&B 4:1". The FDA issued a decision of Substantially Equivalent on May 31, 2024. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2024
- Date Received
- May 2, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Crown And Bridge, Temporary, Resin
- Device Class
- Class II
- Regulation Number
- 872.3770
- Review Panel
- DE
- Submission Type