510(k) K112445
K112445 is an FDA 510(k) premarket notification submitted by Tokuyama Dental Corporation for the device "SOFRELINER TOUGH S". The FDA issued a decision of Substantially Equivalent on Oct 28, 2011. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Tokuyama Dental Corporation has 18 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 2011
- Date Received
- Aug 24, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type
- 510(k)