Comfortsoft Soft Denture Liner System
FDA 510(k) K140146 · Whip Mix Corp.
510(k) numberK140146
Submission
- Device name
- Comfortsoft Soft Denture Liner System
- Applicant
- Whip Mix Corp.
Louisville, KY, US - Received
- January 22, 2014
- Decision date
- April 29, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Comfortsoft Soft Denture Liner System cleared by the FDA?
Comfortsoft Soft Denture Liner System (K140146) received a 510(k) decision of Substantially Equivalent on April 29, 2014, 97 days after the submission was received.
What is the product code of K140146?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.