510(k) K251271
K251271 is an FDA 510(k) premarket notification submitted by Rizhao Huge Biomaterials Company, Ltd. for the device "TempFIT Temporary Crown and Bridge Resin". The FDA issued a decision of Substantially Equivalent on June 23, 2025. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Rizhao Huge Biomaterials Company, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2025
- Date Received
- April 24, 2025
- Clearance Type
- Traditional
- 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