510(k) K140146
K140146 is an FDA 510(k) premarket notification submitted by Whip Mix Corp. for the device "COMFORTSOFT SOFT DENTURE LINER SYSTEM". The FDA issued a decision of Substantially Equivalent on April 29, 2014. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Whip Mix Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2014
- Date Received
- January 22, 2014
- 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